The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for The Acta Formula.
| Device ID | K922703 |
| 510k Number | K922703 |
| Device Name: | THE ACTA FORMULA |
| Classification | Electrocardiograph |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | Wayne L Nethercut |
| Correspondent | Wayne L Nethercut BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-05 |
| Decision Date | 1993-04-27 |