The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll X Series.
Device ID | K142915 |
510k Number | K142915 |
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 |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-07 |
Decision Date | 2014-12-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847946022204 | K142915 | 000 |
00847946021559 | K142915 | 000 |
00847946021498 | K142915 | 000 |
00847946021481 | K142915 | 000 |
00847946021474 | K142915 | 000 |
00847946021467 | K142915 | 000 |
00847946021450 | K142915 | 000 |
00847946021443 | K142915 | 000 |
00847946021436 | K142915 | 000 |
00847946021429 | K142915 | 000 |
00847946021313 | K142915 | 000 |
00847946021566 | K142915 | 000 |
00847946021573 | K142915 | 000 |
00847946021580 | K142915 | 000 |
00847946022174 | K142915 | 000 |
00847946021856 | K142915 | 000 |
00847946021801 | K142915 | 000 |
00847946021795 | K142915 | 000 |
00847946021788 | K142915 | 000 |
00847946021771 | K142915 | 000 |
00847946021764 | K142915 | 000 |
00847946021719 | K142915 | 000 |
00847946021702 | K142915 | 000 |
00847946021610 | K142915 | 000 |
00847946019976 | K142915 | 000 |