The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll Aed Plus With 2010 Aha Guidlines Software Update.
| Device ID | K110154 |
| 510k Number | K110154 |
| Device Name: | ZOLL AED PLUS 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 | 2011-01-19 |
| Decision Date | 2011-02-17 |
| Summary: | summary |