The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll X Series.
Device ID | K141774 |
510k Number | K141774 |
Device Name: | ZOLL X SERIES |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Tammay Shukla |
Correspondent | Tammay Shukla ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Product Code | MKJ |
Subsequent Product Code | CCK |
Subsequent Product Code | DQA |
Subsequent Product Code | DRO |
Subsequent Product Code | DRT |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
Subsequent Product Code | LDD |
Subsequent Product Code | LIX |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-02 |
Decision Date | 2014-11-19 |
Summary: | summary |