The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Urine Meter.
| Device ID | K935578 |
| 510k Number | K935578 |
| Device Name: | URINE METER |
| Classification | Urinometer, Mechanical |
| Applicant | PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Contact | Thomas P Dimaio |
| Correspondent | Thomas P Dimaio PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Product Code | EXR |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1993-12-17 |