The following data is part of a premarket notification filed by Ni-med, Inc. with the FDA for P. Urine Meter, 250cc.
| Device ID | K872824 |
| 510k Number | K872824 |
| Device Name: | P. URINE METER, 250CC |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | NI-MED, INC. 12624 W. 10 MILE RD. South Lyon, MI 48178 |
| Contact | Howard Meade |
| Correspondent | Howard Meade NI-MED, INC. 12624 W. 10 MILE RD. South Lyon, MI 48178 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-16 |
| Decision Date | 1987-10-14 |