The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Formula For Archimed.
| Device ID | K974079 |
| 510k Number | K974079 |
| Device Name: | FORMULA FOR ARCHIMED |
| Classification | Electrocardiograph |
| Applicant | BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Colleen Hittle |
| Correspondent | Colleen Hittle BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. 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 | 1997-10-29 |
| Decision Date | 1998-01-22 |
| Summary: | summary |