K953530 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 8, 1996, 256 days after receiving the submission on July 27, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K953530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1995 |
| Decision Date | April 08, 1996 |
| Days to Decision | 256 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 |