The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Genesis Ii, 2.5/5.0 Mhz S.e/5.0mhz/3.5 16/19 Mm An.
| Device ID | K873032 |
| 510k Number | K873032 |
| Device Name: | GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN |
| Classification | Echocardiograph |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | Robert Courtney |
| Correspondent | Robert Courtney 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 | 1987-08-04 |
| Decision Date | 1988-02-18 |