The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Electrocardiograph Stress Test Firmware Actavis.
| Device ID | K920364 |
| 510k Number | K920364 |
| Device Name: | ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS |
| Classification | Electrocardiograph |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | Carri Stichnoth |
| Correspondent | Carri Stichnoth 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 | 1992-01-28 |
| Decision Date | 1992-03-17 |