K901335 is an FDA 510(k) clearance for the ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on August 10, 1990, 141 days after receiving the submission on March 22, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K901335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1990 |
| Decision Date | August 10, 1990 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DPW - Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |