LOT 440
FDA 510(k) clearance K950087 · decided 1996-02-06
Clearance details
- K-number
- K950087
- Device name
- LOT 440
- Applicant
- Medical Instruments Corporation Mic AG
- Decision
- Substantially Equivalent
- Date received
- 1995-01-10
- Decision date
- 1996-02-06
- Days to decision
- 392 days
- Clearance type
- Traditional
- Product code
- FFT
- Device class
- 1
- Regulation number
- 876.1400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Solothurn, CH
- Third-party review
- No
- Expedited review
- No
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| TRIP CIC CATHETER (K920849) | Tonometrics, Inc. | 1995-03-17 |
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| ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (K925405) | Synectics-Dantec | 1994-09-30 |
| SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (K931963) | Sandhill Scientific, Inc. | 1994-09-28 |
| MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (K913817) | Synectics-Dantec | 1992-06-11 |
| PH METER, MODIFICATION (K914624) | Synectics-Dantec | 1992-04-28 |
Recalls involving this device
No recalls on record reference this clearance.