The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll Propaq M.
Device ID | K102174 |
510k Number | K102174 |
Device Name: | ZOLL PROPAQ M |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Paul Dias |
Correspondent | Paul Dias ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Product Code | DRT |
Subsequent Product Code | CCK |
Subsequent Product Code | DQA |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-02 |
Decision Date | 2010-09-15 |