The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Canmed 451.
| Device ID | K905729 |
| 510k Number | K905729 |
| Device Name: | CANMED 451 |
| Classification | Electrode, Electrocardiograph |
| Applicant | ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830 |
| Contact | Janice M Pevide |
| Correspondent | Janice M Pevide ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1991-02-07 |