FDA Product Code
FDA Product Code GWJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1900
510(k) Clearances — 76 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | 2024-12-19 | Traditional | PDF ↗ |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-03-08 | Traditional | PDF ↗ |
| K220139 | QScreen | Path Medical GmbH | 2022-08-03 | Traditional | PDF ↗ |
| K211147 | ALGO 7i | Path Medical GmbH | 2021-10-14 | Traditional | PDF ↗ |
| K193033 | GSI Audera Pro | Grason Stadler | 2020-04-24 | Traditional | PDF ↗ |
| K163326 | SmartEP | Intelligent Hearing Systems | 2017-09-29 | Traditional | PDF ↗ |
| K162037 | Eclipse with VEMP | Interacoustics A/S | 2017-03-23 | Traditional | PDF ↗ |
| K143670 | ICS CHARTR EP 200 WITH VEMP | Gn Otometrics A/S | 2015-10-23 | Traditional | PDF ↗ |
| K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | Natus Medical Incorporated | 2014-08-22 | Special | PDF ↗ |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | Gn Otometrics | 2014-02-27 | Traditional | PDF ↗ |
| K131141 | EARPROBE | Path Medical GmbH | 2013-06-27 | Traditional | PDF ↗ |
| K123701 | HEARLAB ACA | Frye Electronics, Inc. | 2013-04-05 | Traditional | PDF ↗ |
| K122067 | TYPE 1077 ACCUSCREEN | Gn Otometrics | 2012-09-27 | Traditional | PDF ↗ |
| K111555 | CIRCUMAURAL ADHESIVE REPLACEMENT | R & D Medical Products, Inc. | 2011-07-25 | Traditional | PDF ↗ |
| K103760 | TITAN | Interacoustics A/S | 2011-05-05 | Traditional | PDF ↗ |
| K100661 | EARPROBE | Path Medical GmbH | 2010-07-01 | Traditional | PDF ↗ |
| K092373 | ICS CHARTR EP 200 | Gn Otometrics | 2009-09-03 | Special | PDF ↗ |
| K090579 | SMARTSCREENER-PLUS2 | Intelligent Hearing Systems | 2009-07-07 | Traditional | PDF ↗ |
| K083399 | ICS CHARTR EP 200 | Gn Otometrics A/S | 2009-02-20 | Traditional | PDF ↗ |
| K082035 | MAICO MB 11 WITH BERAPHONE PROBE | Maico Diagnostics | 2009-01-29 | Traditional | PDF ↗ |
| K080060 | VIVOSONIC NEUROSCREEN | Vivosonic, Inc. | 2008-04-04 | Traditional | PDF ↗ |
| K073384 | SMART COUPLER, MODEL M015401 | Intelligent Hearing Systems | 2008-02-28 | Traditional | PDF ↗ |
| K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | Bio-Logic Systems Corp. | 2008-02-05 | Special | PDF ↗ |
| K073665 | ALGO 5 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2008-01-25 | Special | PDF ↗ |
| K070608 | SMARTEP, MODEL M010000 | Intelligent Hearing Systems | 2007-07-18 | Traditional | PDF ↗ |
| K070696 | INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) | Interacoustics A/S | 2007-06-29 | Traditional | PDF ↗ |
| K061443 | SMART USBLITE, MODEL M011120 | Intelligent Hearing Systems | 2006-06-23 | Special | PDF ↗ |
| K043396 | INTEGRITY, MODEL V500 | Vivosonic, Inc. | 2005-01-24 | Traditional | PDF ↗ |
| K031051 | SMARTEP-ASSR, MODEL M811007 | Intelligent Hearing Systems | 2004-02-20 | Traditional | PDF ↗ |
| K030907 | STACKED ABR FOR NAVIGATOR PRO | Bio-Logic Systems Corp. | 2003-05-09 | Special | PDF ↗ |
| K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | Bio-Logic Systems Corp. | 2003-04-28 | Special | PDF ↗ |
| K030823 | ALGO 3I NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2003-04-09 | Special | PDF ↗ |
| K021895 | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM | Bio-Logic Systems Corp. | 2002-07-01 | Special | PDF ↗ |
| K013977 | ECHO-SCREEN T, TA, TD, TDA, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002-06-14 | Traditional | PDF ↗ |
| K021215 | BIO-LOGIC ABAER CUB | Bio-Logic Systems Corp. | 2002-05-15 | Special | PDF ↗ |
| K011842 | SABRE COMPAC | Sle Limited | 2002-01-08 | Traditional | PDF ↗ |
| K012415 | AURIS AEP | Synapsys, Inc. | 2001-12-18 | Traditional | PDF ↗ |
| K013137 | ALGO 3 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 2001-10-16 | Special | PDF ↗ |
| K011746 | MB 11 | Maico Diagnostic GmbH | 2001-08-24 | Traditional | PDF ↗ |
| K002985 | ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS | Ics Medical Corp. | 2000-12-13 | Traditional | PDF ↗ |
| K994149 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. | Bio-Logic Systems Corp. | 1999-12-27 | Special | PDF ↗ |
| K993177 | SABRE | Sle Limited | 1999-11-16 | Traditional | PDF ↗ |
| K991853 | INTERACOUSTICS EP 15 ABR STAND ALONE UNIT | Idem (Int'L Dist. of Electronics For Medicine) | 1999-10-25 | Traditional | PDF ↗ |
| K992807 | BIO-LOGIC EVOKED POTENTIAL FOR ABAER I | Bio-Logic Systems Corp. | 1999-09-14 | Special | PDF ↗ |
| K972157 | EXCEL AV STIM 1000 | Excel Tech. , Ltd. | 1998-01-30 | Traditional | PDF ↗ |
| K960097 | CHARTR EP | Ics Medical Corp. | 1997-02-21 | Traditional | PDF ↗ |
| K953732 | TECA PREMIERE | Medelec , Ltd. | 1995-10-19 | Traditional | PDF ↗ |
| K952080 | CLARITY SYSTEM II | Sonamed Corp. | 1995-09-19 | Traditional | PDF ↗ |
| K936039 | ALGO-2 NEWBORN HEARING SCREENER | Natus Medical, Inc. | 1995-01-05 | Traditional | PDF ↗ |
| K925648 | SMART-SCREENER (AUDITORY) | Intelligent Hearing Systems | 1993-05-11 | Traditional | PDF ↗ |
| K926574 | MODEL 330 SCREENING AUDIO METER, MODIFIED | Virtual Corp. | 1993-03-29 | Traditional | PDF ↗ |
| K913957 | DANTEC COUNTERPOINT MK2(TM) | Dantec Medical, Inc. | 1992-01-30 | Traditional | PDF ↗ |
| K913785 | CORONET 100 | Micro-Shev , Ltd. | 1991-12-31 | Traditional | PDF ↗ |
| K904926 | SMART-EP | Intelligent Hearing Systems | 1991-08-02 | Traditional | PDF ↗ |
| K905632 | NICOLET MAPLELEAF SYSTEM | Nicolet Instrument Corp. | 1991-06-07 | Traditional | PDF ↗ |
| K874193 | MICROSHEV MODEL 2000 | Micro-Shev , Ltd. | 1988-03-21 | Traditional | PDF ↗ |
| K870030 | THE SCREENER GSI 55 ABR SCREENER | Grason-Stadler, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K862906 | TECA/MEDELEC AS-10 SENSOR | Teca, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K863156 | TECA/MEDELEC AUDIOSTAR | Teca, Inc. | 1987-02-03 | Traditional | PDF ↗ |
| K863985 | EVOPORT 100 | Jedmed Instrument Co. | 1987-01-29 | Traditional | PDF ↗ |
| K862430 | SIEGEN HEADPHONES | Siegen Corp. | 1986-09-26 | Traditional | PDF ↗ |
| K862363 | INSERT EARPHONES | Cadwell Laboratories, Inc. | 1986-09-17 | Traditional | PDF ↗ |
| K862361 | 40-HZ AUDITORY EVOKED RESPONSE TEST | Cadwell Laboratories, Inc. | 1986-09-17 | Traditional | PDF ↗ |
| K852687 | ALGO I | Algotek, Inc. | 1985-09-18 | Traditional | PDF ↗ |
| K832510 | EVOKED POTENTIALS SYSTEM MK10 | Amplaid USA, Inc. | 1983-11-25 | Traditional | PDF ↗ |
| K830579 | MULTI-SIGNAL AUDITORY STIMULATOR SM700 | Nicolet Biomedical Instruments | 1983-03-08 | Traditional | PDF ↗ |
| K822177 | AUDIOMETERS (VARIOUS MODELS) | Kelleher Corp. | 1982-08-25 | Traditional | PDF ↗ |
| K813009 | TECA VISUAL/AUDIO STIMULATOR MODEL CS-2 | Teca, Inc. | 1981-12-14 | Traditional | PDF ↗ |
| K810473 | MK6 ERA SYSTEM | Amplaid USA, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K810138 | SYNAP-I INFANT SENSORY ASSESSMENT UNIT | Infant Hearing Assessment Foundation | 1981-04-03 | Traditional | PDF ↗ |
| K810539 | MODEL S10CTCM AUDITORY STIMULATOR | Grass Instrument Co. | 1981-03-17 | Traditional | PDF ↗ |
| K792085 | C-ERA-100 COMPUTERIZED ELECTRIC RESPON | Micro-Shev , Ltd. | 1979-10-30 | Traditional | PDF ↗ |
| K781667 | AMPLAID MARK 4 AND MARK 5 | Amplaid USA, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K780540 | ELECTRIC RESPONSE AUDIOMETER | Life-Tech Instruments, Inc. | 1978-04-21 | Traditional | PDF ↗ |
| K770878 | SIGNAL PROCESSOR/AVERAGER MODEL 7S11 | Medical Systems Corp. | 1977-06-01 | Traditional | PDF ↗ |
| K770268 | SYS. FOR REC. BSER RESPONSES | Life-Tech Instruments, Inc. | 1977-02-28 | Traditional | PDF ↗ |
Product code GWJ · Class II · Neurology. Data: openFDA.