The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll X Series.
Device ID | K133269 |
510k Number | K133269 |
Device Name: | ZOLL X SERIES |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Tanmay B Shukla |
Correspondent | Tanmay B Shukla 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-24 |
Decision Date | 2014-05-22 |
Summary: | summary |