K904600 is an FDA 510(k) clearance for the L582 TRANSDUCER. This device is classified as a Monitor, Fetal Doppler Ultrasound (Class II - Special Controls, product code MAA).
Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on June 24, 1991, 257 days after receiving the submission on October 10, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K904600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1990 |
| Decision Date | June 24, 1991 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | MAA — Monitor, Fetal Doppler Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |