URDYN 5000 (UROFLOWMETER)
FDA 510(k) clearance K860368 · decided 1986-04-23
Clearance details
- K-number
- K860368
- Device name
- URDYN 5000 (UROFLOWMETER)
- Applicant
- Dantec Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-03
- Decision date
- 1986-04-23
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- FFO
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Allendale, NJ, 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 |
|---|---|---|
| SPACE-OR RETRACTOR (K993544) | Advanced Surgical Concepts (Asc) | 1999-12-22 |
| KODNER ANAL PERIONEAL RETRACTOR (K870897) | Sur-Med Instruments, Inc. | 1987-06-04 |
| URODYN 1000 (K853119) | Dantec Electronics, Inc. | 1985-10-04 |
| THE KENDALL URINARY OUTPUT MONITOR (K852083) | The Kendal Co. | 1985-09-20 |
Recalls involving this device
No recalls on record reference this clearance.