FLOLAB
FDA 510(k) clearance K951442 · decided 1995-08-24
Clearance details
- K-number
- K951442
- Device name
- FLOLAB
- Applicant
- Synectics Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-29
- Decision date
- 1995-08-24
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- EXY
- Device class
- 2
- Regulation number
- 876.1800
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- S-116 28 Stockholm, SE
- Third-party review
- No
- Expedited review
- No
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| MICROFLO (K904557) | Life-Tech Intl., Inc. | 1990-12-28 |
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| HOME URODATA SYSTEM(TM) (K900770) | Biodan Medical Systems, Ltd. | 1990-06-08 |
| ULTRACOMPACT (K894968) | Eutectic Electronics, Inc. | 1989-11-08 |
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Recalls involving this device
No recalls on record reference this clearance.