K934638 is an FDA 510(k) clearance for the REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8. This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Koven Technology, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 13, 1994, 231 days after receiving the submission on September 24, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K934638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1993 |
| Decision Date | May 13, 1994 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | JOP - Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |