The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Ami Cardio-pad.
| Device ID | K860283 |
| 510k Number | K860283 |
| Device Name: | AMI CARDIO-PAD |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Contact | Thomas |
| Correspondent | Thomas ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-03-31 |