The following data is part of a premarket notification filed by Siemens-pacesetter, Inc. with the FDA for Afp Cardiac Pacing System Model 283.
| Device ID | K942440 |
| 510k Number | K942440 |
| Device Name: | AFP CARDIAC PACING SYSTEM MODEL 283 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW CT Sylmar, CA 91392 |
| Contact | Nestor Kusierz |
| Correspondent | Nestor Kusierz SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW CT Sylmar, CA 91392 |
| 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 | 1994-05-20 |
| Decision Date | 1994-08-08 |