K905369 is an FDA 510(k) clearance for the UST-2266U-5 CW DOPPLER TRANSDUCER. This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on February 11, 1991, 74 days after receiving the submission on November 29, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K905369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1990 |
| Decision Date | February 11, 1991 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | JOP - Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |