The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for The New 1600 Electrode.
| Device ID | K812878 |
| 510k Number | K812878 |
| Device Name: | THE NEW 1600 ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | ANDOVER MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-14 |
| Decision Date | 1981-11-02 |