The following data is part of a premarket notification filed by Teletronics, Inc. with the FDA for Model 5650 Optimate Personal Programmer.
| Device ID | K884522 |
| 510k Number | K884522 |
| Device Name: | MODEL 5650 OPTIMATE PERSONAL PROGRAMMER |
| Classification | Programmer, Pacemaker |
| Applicant | TELETRONICS, INC. ATTORNEY-AT-LAW 40 CRANE HILL ROAD Suffield, CT 06078 |
| Contact | C Nealon |
| Correspondent | C Nealon TELETRONICS, INC. ATTORNEY-AT-LAW 40 CRANE HILL ROAD Suffield, CT 06078 |
| Product Code | KRG |
| CFR Regulation Number | 870.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-27 |
| Decision Date | 1989-08-25 |