K992580 is an FDA 510(k) clearance for the FETAL ASSESSMENT CAP. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on October 18, 1999, 77 days after receiving the submission on August 2, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K992580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1999 |
| Decision Date | October 18, 1999 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |