FDA Product Code
FDA Product Code ERA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4770
510(k) Clearances — 56 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123821 | AIO HD OTOSCOPE | Blue Focus | 2013-05-17 | Traditional | PDF ↗ |
| K121326 | LANTOS 3D EAR SCANNER | Lantos Technologies | 2013-01-25 | Traditional | PDF ↗ |
| K110326 | OSRAM ITOS | Osram Sylvania, Inc. | 2011-10-27 | Traditional | PDF ↗ |
| K945264 | OPTUS OTOSCOPES | Optus, Inc. | 1996-02-02 | Traditional | PDF ↗ |
| K955043 | WELCH ALLYN BI-OTOSCOPE | Welch Allyn, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K952578 | WELCH ALLY OTOSCOPE | Welch Allyn, Inc. | 1995-07-10 | Traditional | PDF ↗ |
| K950913 | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | Rudolf Riester GmbH & Co. KG | 1995-05-12 | Traditional | PDF ↗ |
| K950788 | OTOSCOPE A-34 | Neitz Instruments Company, Ltd. | 1995-05-03 | Traditional | PDF ↗ |
| K951050 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K951049 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K951255 | IMEDGE VIDEO OSTOSCOPE (ANALOG) | Introspect, Inc. | 1995-04-13 | Traditional | PDF ↗ |
| K950983 | IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE | Introspect, Inc. | 1995-04-12 | Traditional | PDF ↗ |
| K950787 | WELCH ALLYN OTOSCOPE | Welch Allyn, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K946043 | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG | Rudolf Riester GmbH & Co. KG | 1995-03-08 | Traditional | PDF ↗ |
| K943721 | OTOVIEW TELESCOPIC OTOSCOPES | Smith & Nephew, Inc. | 1994-11-18 | Traditional | PDF ↗ |
| K944897 | HOME CARE EAR EXAMINATIO KIT | Home Care Instruments, Inc. | 1994-11-08 | Traditional | PDF ↗ |
| K943731 | VIDEO OTOSCOPE | Cuda Products Co. | 1994-10-11 | Traditional | PDF ↗ |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | Jedmed Instrument Co. | 1994-09-23 | Traditional | PDF ↗ |
| K943916 | VIDEOTOSCOPE | Welch Allyn, Inc. | 1994-08-25 | Traditional | PDF ↗ |
| K942244 | REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE | National Custom Ent., Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K941659 | AURAL-CAM, VIDEO EAR, VID RX | Gracefully Yours, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K932259 | CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE | Clarus Medical Systems, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K932503 | RI-MINI | Rudolf Riester GmbH & Co. KG | 1993-10-08 | Traditional | PDF ↗ |
| K925753 | UNI III | Rudolf Riester GmbH & Co. KG | 1993-10-08 | Traditional | PDF ↗ |
| K932506 | RI-SCOPE (S) | Rudolf Riester GmbH & Co. KG | 1993-10-08 | Traditional | PDF ↗ |
| K925752 | STANDARD | Rudolf Riester GmbH & Co. KG | 1993-10-08 | Traditional | PDF ↗ |
| K932505 | RI-STAR | Rudolf Riester GmbH & Co. KG | 1993-10-08 | Traditional | PDF ↗ |
| K925758 | OTOSCOPE | Rudolf Riester GmbH & Co. KG | 1993-08-03 | Traditional | PDF ↗ |
| K925759 | UNI I | Rudolf Riester GmbH & Co. KG | 1993-07-26 | Traditional | PDF ↗ |
| K923830 | XOMED-TREACE ALPHASCOPE | Xomed-Treace, Inc. | 1992-11-09 | Traditional | PDF ↗ |
| K924025 | OTO-BRITE HANDLE | Jedmed Instrument Co. | 1992-11-06 | Traditional | PDF ↗ |
| K923304 | FAMILY EAR SCOPE MODEL 29001S | Ear Care of So. Ca., Inc. | 1992-10-21 | Traditional | PDF ↗ |
| K922752 | STARKEY LABORATORIES OTOSCOPE | Starkey Laboratories, Inc. | 1992-09-04 | Traditional | PDF ↗ |
| K920322 | OPTIEAR | Nankivell Industries, Inc. | 1992-04-23 | Traditional | PDF ↗ |
| K915537 | EARBEAR OTOSCOPE | Earbear Co. | 1992-01-24 | Traditional | PDF ↗ |
| K911650 | PEDIA PALS | Pedia Pals, Inc. | 1991-10-17 | Traditional | PDF ↗ |
| K904659 | DR. DEDO'S FAMILY EAR EXAMINATION KIT | Panex Corp. | 1991-04-30 | Traditional | PDF ↗ |
| K904802 | VIDEO OTOSCOPE | Jedmed Instrument Co. | 1991-01-22 | Traditional | PDF ↗ |
| K902205 | OTOSCOPE | Truphatek, Ltd. | 1990-08-14 | Traditional | PDF ↗ |
| K896274 | TYMPANOSCOPE | Jedmed Instrument Co. | 1990-01-26 | Traditional | PDF ↗ |
| K862661 | D.L. SCOPE(R) OTOSCOPE | North American Medical Products, Inc. | 1986-08-08 | Traditional | PDF ↗ |
| K862621 | I22 INITIALES | Oticon Corp. | 1986-08-01 | Traditional | PDF ↗ |
| K862624 | I81 CITE | Oticon Corp. | 1986-08-01 | Traditional | PDF ↗ |
| K851745 | 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B | Artiberia | 1985-08-29 | Traditional | PDF ↗ |
| K851746 | 1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS. | Artiberia | 1985-05-29 | Traditional | PDF ↗ |
| K840593 | DISPOSA-SPEC | Plasti-Products, Inc. | 1984-07-13 | Traditional | PDF ↗ |
| K831614 | INSPETOSCOPE | Terayco Intl., Ltd. | 1983-08-12 | Traditional | PDF ↗ |
| K831709 | AUDIOSCOPE #23000 W/71123 CHARGING STAND | Welch Allyn, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K813299 | CONPHAR OTOSCOPE/OPTHALMASCOPE | Conphar, Inc. | 1982-01-19 | Traditional | PDF ↗ |
| K813305 | CONPHAR OTOSCOPE | Conphar, Inc. | 1982-01-19 | Traditional | PDF ↗ |
| K813003 | P.P.P. TREATMENT CABINET | Precision Professional Products | 1981-11-06 | Traditional | PDF ↗ |
| K800365 | EARSCOPE | Nash & Assoc. | 1980-03-10 | Traditional | PDF ↗ |
| K782142 | ILLIMINATOR, MODEL 265 NASAL | Welch Allyn, Inc. | 1979-01-26 | Traditional | PDF ↗ |
| K781029 | OTOSCOPE, DIAG. MODELS 20100 & 20200 | Welch Allyn, Inc. | 1978-06-28 | Traditional | PDF ↗ |
| K770770 | WALL CHARGER, MODEL #79111 | Welch Allyn, Inc. | 1977-04-29 | Traditional | PDF ↗ |
| K770769 | OTOSCOPE/ILLUMINATOR, MODEL #21100 | Welch Allyn, Inc. | 1977-04-29 | Traditional | PDF ↗ |
Product code ERA · Class I · Ear, Nose, Throat. Data: openFDA.