The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Pad With Cpr Aid.
Device ID | K011541 |
510k Number | K011541 |
Device Name: | ZOLL PAD WITH CPR AID |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 -4420 |
Contact | Paul Dias |
Correspondent | Paul Dias ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 -4420 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-18 |
Decision Date | 2002-04-11 |