The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll Propaq Md.
Device ID | K100654 |
510k Number | K100654 |
Device Name: | ZOLL PROPAQ MD |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
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 | LDD |
Subsequent Product Code | CCK |
Subsequent Product Code | DQA |
Subsequent Product Code | DRO |
Subsequent Product Code | DRT |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-08 |
Decision Date | 2010-07-29 |
Summary: | summary |