The following data is part of a premarket notification filed by Telectronics Pacing Systems, Inc. with the FDA for Maxim Pf Models 033-581/033-590.
| Device ID | K961118 |
| 510k Number | K961118 |
| Device Name: | MAXIM PF MODELS 033-581/033-590 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY Englewood, CO 80112 |
| Contact | Andrew Cleeland |
| Correspondent | Andrew Cleeland TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY Englewood, CO 80112 |
| 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 | 1996-03-20 |
| Decision Date | 1996-07-15 |