TRANS/R - FP(3)
FDA 510(k) clearance K900016 · decided 1990-06-11
Clearance details
- K-number
- K900016
- Device name
- TRANS/R - FP(3)
- Applicant
- CIVCO Medical Instruments Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-02
- Decision date
- 1990-06-11
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- FCY
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kalona, IA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 (K093718) | Zutron Medical, LLC | 2010-02-22 |
| ANEROID BLOOD PRESSURE GAUGE (K904376) | Biomedical Dynamics, Inc. | 1990-12-20 |
Recalls involving this device
No recalls on record reference this clearance.