The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Dialog Programmer 700 - Program Version 6.37.
| Device ID | K860546 |
| 510k Number | K860546 |
| Device Name: | DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 |
| Classification | Programmer, Pacemaker |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Anita Powe |
| Correspondent | Anita Powe PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Product Code | KRG |
| CFR Regulation Number | 870.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-13 |
| Decision Date | 1986-04-23 |