SAF-D-FIB
Electrode, Electrocardiograph
MEDTRONIC ANDOVER MEDICAL, INC.
The following data is part of a premarket notification filed by Medtronic Andover Medical, Inc. with the FDA for Saf-d-fib.
Pre-market Notification Details
| Device ID | K852469 |
| 510k Number | K852469 |
| Device Name: | SAF-D-FIB |
| Classification | Electrode, Electrocardiograph |
| Applicant | MEDTRONIC ANDOVER MEDICAL, INC. 341 MIDDLESEX ST. Lowell, MA 01852 |
| Contact | Edward Shaughnessy |
| Correspondent | Edward Shaughnessy MEDTRONIC ANDOVER MEDICAL, INC. 341 MIDDLESEX ST. Lowell, MA 01852 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-13 |
| Decision Date | 1985-09-16 |
Trademark Results [SAF-D-FIB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAF-D-FIB 73582812 1412188 Live/Registered |
MEDTRONIC, INC. 1986-02-14 |
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