K955019 is an FDA 510(k) clearance for the UROTRACT I. This device is classified as a Table, Cystometric, Non-electric And Accessories (Class I - General Controls, product code KQS).
Submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on December 6, 1995, 34 days after receiving the submission on November 2, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 876.4890.
| 510(k) Number | K955019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1995 |
| Decision Date | December 06, 1995 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KQS — Table, Cystometric, Non-electric And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4890 |