The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Cardiotrak.
Device ID | K802089 |
510k Number | K802089 |
Device Name: | CARDIOTRAK |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-02 |
Decision Date | 1980-09-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARDIOTRAK 73201158 1141580 Dead/Cancelled |
Cardiac Pacemakers, Inc. 1979-01-24 |