The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Disposable Electrode, #1610.
| Device ID | K812276 |
| 510k Number | K812276 |
| Device Name: | DISPOSABLE ELECTRODE, #1610 |
| 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 | 1981-08-13 |
| Decision Date | 1981-09-25 |