FFT — Electrode, Ph, Stomach Class I
FDA product code FFT covers "Electrode, Ph, Stomach", a Class I medical device regulated under 21 CFR 876.1400. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FFT
- Device Class
- Class I
- Regulation Number
- 876.1400
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K102543 | given imaging | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | December 1, 2010 |
| K013951 | sandhill scientific | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | February 28, 2002 |
| K002028 | endonetics | BRAVO PH MONITORING SYSTEM | September 29, 2000 |
| K961346 | synectics-dantec | PH ANALYSIS MODULE | January 29, 1997 |
| K950087 | medical instruments corporation mic | LOT 440 | February 6, 1996 |
| K955018 | instrumentarium | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR | January 30, 1996 |
| K945069 | oakfield instruments | FLEXILOG 2000 | June 13, 1995 |
| K920849 | tonometrics | TRIP CIC CATHETER | March 17, 1995 |
| K934434 | cybermed control systems | CYBERRX MODEL 7200 | January 24, 1995 |
| K925405 | synectics-dantec | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | September 30, 1994 |
| K931963 | sandhill scientific | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | September 28, 1994 |
| K913817 | synectics-dantec | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | June 11, 1992 |
| K914624 | synectics-dantec | PH METER, MODIFICATION | April 28, 1992 |
| K912772 | sandhill scientific | SUPERLOGGER | February 7, 1992 |
| K913387 | synectics-dantec | DIGITRAPPER MARK III | December 27, 1991 |
| K911825 | tonometrics | TRIP(TM) NASOGASTRIC SUMP CATHETER | July 23, 1991 |
| K910694 | zinetics medical | ZINETICS INTERNAL REFERENCE PROBE | May 17, 1991 |
| K903646 | medics instrument | GASTROGRAPH | November 5, 1990 |
| K902366 | synectics-dantec | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT | June 8, 1990 |
| K896288 | oakfield instruments | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | May 4, 1990 |