The following data is part of a premarket notification filed by Pacesetter, Inc. with the FDA for Afp Cardiac Pacing System Model 283 (modification).
| Device ID | K954714 |
| 510k Number | K954714 |
| Device Name: | AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) |
| Classification | Permanent Pacemaker Electrode |
| Applicant | PACESETTER, INC. 15900 VALLEY VIEW COURT P.O. BOX 9221 Sylmar, CA 91342 -3577 |
| Contact | Paul Mason |
| Correspondent | Paul Mason PACESETTER, INC. 15900 VALLEY VIEW COURT P.O. BOX 9221 Sylmar, CA 91342 -3577 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1996-02-01 |