The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Fastrace Iii, Ecg Electrode.
| Device ID | K860636 |
| 510k Number | K860636 |
| Device Name: | FASTRACE III, ECG ELECTRODE |
| Classification | Electrocardiograph |
| Applicant | ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Contact | Nilay K Sankalia |
| Correspondent | Nilay K Sankalia ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-21 |
| Decision Date | 1986-05-09 |