The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Aed Plus.
Device ID | K033474 |
510k Number | K033474 |
Device Name: | ZOLL AED PLUS |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Paul Dias |
Correspondent | Paul Dias ZOLL MEDICAL CORP. 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 | 2003-11-03 |
Decision Date | 2004-05-21 |
Summary: | summary |