The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Cardiotest 2200.
Device ID | K790503 |
510k Number | K790503 |
Device Name: | CARDIOTEST 2200 |
Classification | Tester, Pacemaker Electrode Function |
Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTA |
CFR Regulation Number | 870.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-13 |
Decision Date | 1979-05-17 |