K913209 is an FDA 510(k) clearance for the ACCESSORY TO GENESIS III (GCFM). This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 15, 1992, 301 days after receiving the submission on July 19, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K913209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1991 |
| Decision Date | May 15, 1992 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | DXK — Echocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2330 |