FDA Product Code
FDA Product Code FFT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1400
510(k) Clearances — 49 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | Given Imaging , Ltd. | 2010-12-01 | Traditional | PDF ↗ |
| K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | Sandhill Scientific, Inc. | 2002-02-28 | Traditional | PDF ↗ |
| K002028 | BRAVO PH MONITORING SYSTEM | Endonetics, Inc. | 2000-09-29 | Traditional | PDF ↗ |
| K961346 | PH ANALYSIS MODULE | Synectics-Dantec | 1997-01-29 | Traditional | PDF ↗ |
| K950087 | LOT 440 | Medical Instruments Corporation Mic AG | 1996-02-06 | Traditional | PDF ↗ |
| K955018 | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR | Instrumentarium Corp. | 1996-01-30 | Traditional | PDF ↗ |
| K945069 | FLEXILOG 2000 | Oakfield Instruments, Ltd. | 1995-06-13 | Traditional | PDF ↗ |
| K920849 | TRIP CIC CATHETER | Tonometrics, Inc. | 1995-03-17 | Traditional | PDF ↗ |
| K934434 | CYBERRX MODEL 7200 | Cybermed Control Systems, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K925405 | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | Synectics-Dantec | 1994-09-30 | Traditional | PDF ↗ |
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | Sandhill Scientific, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | Synectics-Dantec | 1992-06-11 | Traditional | PDF ↗ |
| K914624 | PH METER, MODIFICATION | Synectics-Dantec | 1992-04-28 | Traditional | PDF ↗ |
| K912772 | SUPERLOGGER | Sandhill Scientific, Inc. | 1992-02-07 | Traditional | PDF ↗ |
| K913387 | DIGITRAPPER MARK III | Synectics-Dantec | 1991-12-27 | Traditional | PDF ↗ |
| K911825 | TRIP(TM) NASOGASTRIC SUMP CATHETER | Tonometrics, Inc. | 1991-07-23 | Traditional | PDF ↗ |
| K910694 | ZINETICS INTERNAL REFERENCE PROBE | Zinetics Medical, Inc. | 1991-05-17 | Traditional | PDF ↗ |
| K903646 | GASTROGRAPH | Medics Instrument Corp. | 1990-11-05 | Traditional | PDF ↗ |
| K902366 | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT | Synectics-Dantec | 1990-06-08 | Traditional | PDF ↗ |
| K896288 | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | Oakfield Instruments, Ltd. | 1990-05-04 | Traditional | PDF ↗ |
| K883960 | GIPHY MONITOR | Vascular Technology Incorporated | 1989-10-04 | Traditional | PDF ↗ |
| K891410 | NASOGASTRIC PH SUCTION CATHETER, ST-5001 | Sensatronix Medical Systems, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K883234 | TONOMITOR (TM) + SUMP | Tonometrics, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K881706 | PROXIMA 1 PH MONITOR | Technomanagement, Inc. C/O C.G. | 1988-07-12 | Traditional | PDF ↗ |
| K874709 | DIAMOND MEDICAL, INC. MODEL DM 800 | Diamond Medical, Inc. | 1988-02-08 | Traditional | PDF ↗ |
| K874710 | DIAMOND MEDICAL, INC. MODEL DM 600 | Diamond Medical, Inc. | 1988-02-08 | Traditional | PDF ↗ |
| K875369 | MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT | Diamond Medical, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K871921 | GENERAL PURPOSE COMBINATION PH ELECTRODE | Chemfet Corp. | 1987-10-20 | Traditional | PDF ↗ |
| K871922 | PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA. | Chemfet Corp. | 1987-10-20 | Traditional | PDF ↗ |
| K872929 | PH MONITORING SYSTEM | Sensatronix Medical Systems, Inc. | 1987-08-10 | Traditional | PDF ↗ |
| K871282 | SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE | Synectics-Dantec | 1987-06-10 | Traditional | PDF ↗ |
| K870606 | TONOMITOR(TM) | Tonometrics Holdings SA C/O Mackeen Consultants | 1987-04-10 | Traditional | PDF ↗ |
| K863298 | DIAMOND MEDICAL, INC., MODEL DM 700 | Diamond Medical, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K862727 | ZINETICS GASTROMETER (TM) | Zinetics Medical Technology Corp. | 1986-11-19 | Traditional | PDF ↗ |
| K862929 | SYNECTICS MOTILITY SYSTEM | Synectics-Dantec | 1986-10-20 | Traditional | PDF ↗ |
| K862536 | MODEL 1010 AMBULATORY PH MONITORING SYSTEM | Oxford Medilog, Inc. | 1986-09-12 | Traditional | PDF ↗ |
| K854514 | AMBI-24 PH/PRESSURE MONITOR | Biosearch Medical Products, Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K853280 | FOUR CHANNEL PH PROBE | Akron City Hospital | 1985-12-02 | Traditional | PDF ↗ |
| K853648 | SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO | Synectics-Dantec | 1985-11-18 | Traditional | PDF ↗ |
| K852289 | MODEL SA3 ESOPHAGEAL PH ELECTRODE | World Precision Instruments, Inc. | 1985-07-25 | Traditional | PDF ↗ |
| K850778 | SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE | Settler Medical Electronics, Inc. | 1985-06-13 | Traditional | PDF ↗ |
| K850361 | SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E | Synectics-Dantec | 1985-05-01 | Traditional | PDF ↗ |
| K850074 | ESOPHOGEAL PH CATHETER | Biosearch Medical Products, Inc. | 1985-02-14 | Traditional | PDF ↗ |
| K842690 | SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT | Synectics AB | 1984-11-08 | Traditional | PDF ↗ |
| K841384 | PROXIMA 1 PH MONITOR | American Endoscopy, Inc. | 1984-07-19 | Traditional | PDF ↗ |
| K834512 | SANDMILL RMS | Sandhill Scientific, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K822815 | MODEL 700 GASTROREFLUX MONITOR/AMALYZER | Del Mar Avionics | 1982-10-22 | Traditional | PDF ↗ |
| K820566 | PATIENT ISOLATOR #S-10/D-10 | Microelectrodes, Inc. | 1982-03-23 | Traditional | PDF ↗ |
| K811083 | ESOPHAGEAL MOTILITY PROBE | Konigsberg Instruments, Inc. | 1981-08-13 | Traditional | PDF ↗ |
Product code FFT · Class I · Gastroenterology, Urology. Data: openFDA.