The following data is part of a premarket notification filed by Micromedical, Inc. with the FDA for Biolog 3000 Electrocardiograph.
| Device ID | K974351 |
| 510k Number | K974351 |
| Device Name: | BIOLOG 3000 ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | MICROMEDICAL, INC. 255 REVERE DR., SUITE 111 Northbrook, IL 60062 |
| Contact | Malcom Castle |
| Correspondent | Malcom Castle MICROMEDICAL, INC. 255 REVERE DR., SUITE 111 Northbrook, IL 60062 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-19 |
| Decision Date | 1998-04-01 |
| Summary: | summary |