The following data is part of a premarket notification filed by Vitalmetrics, Inc. with the FDA for Urinary Drainage Container 2012-with.
| Device ID | K843441 |
| 510k Number | K843441 |
| Device Name: | URINARY DRAINAGE CONTAINER 2012-WITH |
| Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Applicant | VITALMETRICS, INC. 6341 NANCY RIDGE DRIVE San Diego , CA 92121 - |
| Contact | Anne Wister |
| Correspondent | Anne Wister VITALMETRICS, INC. 6341 NANCY RIDGE DRIVE San Diego , CA 92121 - |
| Product Code | FFG |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-04 |
| Decision Date | 1985-01-03 |