• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K120350
Device Name EXTENDED LIFE BATTERY
Original Applicant
AED BATTERY EXCHANGE, LLC
1000 brown street
suite 310
wauconda,  IL  60084
Original Contact keith hochhalter
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/06/2012
Decision Date 11/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-