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 |