URINE METER
FDA 510(k) clearance K935578 · decided 1993-12-17
Clearance details
- K-number
- K935578
- Device name
- URINE METER
- Applicant
- Puritas Health Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-18
- Decision date
- 1993-12-17
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- EXR
- Device class
- 2
- Regulation number
- 876.1800
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- New Milford, CT, 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 |
|---|---|---|
| URINARY DRAINAGE BAG (K934142) | Key Medical Services, Inc. | 1994-05-17 |
| KENDALL PEDIATRIC URINE METER (K911258) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1991-04-25 |
| UNOMETER 500 (K896732) | Unoplast A/S | 1990-11-02 |
| COMPRESS AND SKULLCAP, HEAD DRESSING (K870240) | Fraass Survival Systems, Inc. | 1987-02-20 |
| DOVER URINE METER (K771561) | Will Ross Co. | 1977-09-07 |
| URINE TESTER, MODEL NO. 707 (K770423) | Brother Scientific Products, Inc. | 1977-06-03 |
| URINE TESTER, MODEL 701 (K770939) | Brother Scientific Products, Inc. | 1977-06-03 |
| BARD URINE METER W/ BAG (K761083) | C.R. Bard, Inc. | 1977-01-26 |
Recalls involving this device
No recalls on record reference this clearance.