The following data is part of a premarket notification filed by Medtronic Andover Medical, Inc. with the FDA for Medtronic Andover Medical Saf-d-fib Model 1220-002.
| Device ID | K903018 |
| 510k Number | K903018 |
| Device Name: | MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | MEDTRONIC ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830 |
| Contact | Janice Pevide |
| Correspondent | Janice Pevide MEDTRONIC ANDOVER MEDICAL, INC. 60 NEWARK ST. Haverhill, MA 01830 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1990-12-03 |