The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Reviver.
Device ID | K972241 |
510k Number | K972241 |
Device Name: | ZOLL REVIVER |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
Contact | Maura Mcguire |
Correspondent | Maura Mcguire ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-16 |
Decision Date | 1998-03-16 |