The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Model 5600b Programmer, Pacemaker.
Device ID | K871986 |
510k Number | K871986 |
Device Name: | MODEL 5600B PROGRAMMER, PACEMAKER |
Classification | Programmer, Pacemaker |
Applicant | TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
Contact | William C Nealon |
Correspondent | William C Nealon TELECTRONICS, INC. 40 CRANE HILL RD. 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 | 1987-05-22 |
Decision Date | 1987-06-24 |