The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Test Magnet.
Device ID | K813153 |
510k Number | K813153 |
Device Name: | TEST MAGNET |
Classification | Magnet, Test, Pacemaker |
Applicant | PACESETTER SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DTG |
CFR Regulation Number | 870.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-06 |
Decision Date | 1981-12-02 |