Product code FFT
- Device name
- Electrode, Ph, Stomach
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.1400
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | Given Imaging , Ltd. | 2010-12-01 |
| K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | Sandhill Scientific, Inc. | 2002-02-28 |
| K002028 | BRAVO PH MONITORING SYSTEM | Endonetics, Inc. | 2000-09-29 |
| K961346 | PH ANALYSIS MODULE | Synectics-Dantec | 1997-01-29 |
| K950087 | LOT 440 | Medical Instruments Corporation Mic AG | 1996-02-06 |
| K955018 | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR | Instrumentarium Corp. | 1996-01-30 |
| K945069 | FLEXILOG 2000 | Oakfield Instruments, Ltd. | 1995-06-13 |
| K920849 | TRIP CIC CATHETER | Tonometrics, Inc. | 1995-03-17 |
| K934434 | CYBERRX MODEL 7200 | Cybermed Control Systems, Inc. | 1995-01-24 |
| K925405 | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | Synectics-Dantec | 1994-09-30 |
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | Sandhill Scientific, Inc. | 1994-09-28 |
| K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | Synectics-Dantec | 1992-06-11 |
| K914624 | PH METER, MODIFICATION | Synectics-Dantec | 1992-04-28 |
| K912772 | SUPERLOGGER | Sandhill Scientific, Inc. | 1992-02-07 |
| K913387 | DIGITRAPPER MARK III | Synectics-Dantec | 1991-12-27 |
| K911825 | TRIP(TM) NASOGASTRIC SUMP CATHETER | Tonometrics, Inc. | 1991-07-23 |
| K910694 | ZINETICS INTERNAL REFERENCE PROBE | Zinetics Medical, Inc. | 1991-05-17 |
| K903646 | GASTROGRAPH | Medics Instrument Corp. | 1990-11-05 |
| K902366 | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT | Synectics-Dantec | 1990-06-08 |
| K896288 | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | Oakfield Instruments, Ltd. | 1990-05-04 |
| K883960 | GIPHY MONITOR | Vascular Technology Incorporated | 1989-10-04 |
| K891410 | NASOGASTRIC PH SUCTION CATHETER, ST-5001 | Sensatronix Medical Systems, Inc. | 1989-06-23 |
| K883234 | TONOMITOR (TM) + SUMP | Tonometrics, Inc. | 1988-10-12 |
| K881706 | PROXIMA 1 PH MONITOR | Technomanagement, Inc. C/O C.G. | 1988-07-12 |
| K874709 | DIAMOND MEDICAL, INC. MODEL DM 800 | Diamond Medical, Inc. | 1988-02-08 |
| K874710 | DIAMOND MEDICAL, INC. MODEL DM 600 | Diamond Medical, Inc. | 1988-02-08 |
| K875369 | MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT | Diamond Medical, Inc. | 1988-02-05 |
| K871921 | GENERAL PURPOSE COMBINATION PH ELECTRODE | Chemfet Corp. | 1987-10-20 |
| K871922 | PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA. | Chemfet Corp. | 1987-10-20 |
| K872929 | PH MONITORING SYSTEM | Sensatronix Medical Systems, Inc. | 1987-08-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B989PCCK3300 | Heidelberg pH Capsule System | Heidelberg Medical Inc | 2020-11-13 |
| B989HPHDS180 | Heidelberg pH Capsule System | Heidelberg Medical Inc | 2020-11-13 |
| B989HCNS180 | Heidelberg pH Capsule System | Heidelberg Medical Inc | 2020-11-13 |
| B989EC1150 | Heidelberg pH Capsule System | Heidelberg Medical Inc | 2020-11-13 |
| 04260167483825 | Versaflex | Given Imaging, Inc. | 2018-09-06 |
| 04260167483900 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483931 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483948 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483955 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483962 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483894 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483887 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483870 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483863 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483856 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483849 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483832 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483795 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483818 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483788 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483771 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483764 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483757 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 04260167483740 | Versaflex | Given Imaging, Inc. | 2018-08-29 |
| 08717775952893 | 1 channel pH antimony, 6.4 Fr | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775952992 | 2 channel pH antimony, 21 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775952978 | 2 channel pH antimony, 15 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775952954 | 2 channel pH antimony, 10 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775952930 | 2 channel pH antimony, 5 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775952916 | 1 channel pH antimony, Pediatric, 5 Fr | Medical Measurement Systems B.V. | 2016-09-23 |