510(k) K881706
- Device
- PROXIMA 1 PH MONITOR
- Applicant
- TECHNOMANAGEMENT, INC. C/O C.G.
- 510(k) number
- K881706
- Product code
- FFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-12
- Date received
- 1988-04-19
- Regulation
- 876.1400
- Classification name
- Electrode, Ph, Stomach
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CONSTANCE G BUNDY
- Address
- 6470 Riverview Ter. Findley MN US 55432 55432
FDA Registration Numbers#
- 3039167637
- 3009106214
- 3011219572
- 3007662958
- 9710107
- 3018094310
- 3016854619
- 2023374
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FFT #
| 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 |
Legacy Summary#
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FDA Review#
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