The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Accessory To Genesis Iii (gcfm).
| Device ID | K913209 |
| 510k Number | K913209 |
| Device Name: | ACCESSORY TO GENESIS III (GCFM) |
| Classification | Echocardiograph |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | William E Mckay |
| Correspondent | William E Mckay BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-19 |
| Decision Date | 1992-05-15 |