SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
FDA 510(k) clearance K931963 · decided 1994-09-28
Clearance details
- K-number
- K931963
- Device name
- SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
- Applicant
- Sandhill Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-21
- Decision date
- 1994-09-28
- Days to decision
- 525 days
- Clearance type
- Traditional
- Product code
- FFT
- Device class
- 1
- Regulation number
- 876.1400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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| MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (K913817) | Synectics-Dantec | 1992-06-11 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility sy recall (Z-0104-04) | Sandhill Scientific, Inc | 2003-11-11 |
| ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individual recall (Z-0466-03) | Sandhill Scientific, Inc | 2003-01-23 |