The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll Aedpro With 2010 Aha Guidelines Software Update.
Device ID | K110526 |
510k Number | K110526 |
Device Name: | ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Eileen M Boyle |
Correspondent | Eileen M Boyle ZOLL MEDICAL CORPORATION 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 | 2011-02-24 |
Decision Date | 2011-03-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847946099329 | K110526 | 000 |
00847946016838 | K110526 | 000 |
00847946016821 | K110526 | 000 |
00847946016166 | K110526 | 000 |
00847946016159 | K110526 | 000 |
00847946016142 | K110526 | 000 |
00847946016135 | K110526 | 000 |
00847946016128 | K110526 | 000 |