The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll E Series With 2010 Aha Guidlines Software Update.
Device ID | K110168 |
510k Number | K110168 |
Device Name: | ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Eileen M Boyle |
Correspondent | Eileen M Boyle ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-20 |
Decision Date | 2011-02-17 |
Summary: | summary |