Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K130684
Device Name PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
Applicant
Philips Medical Systems
22100 Bothell Everett Highway
Bothell,  WA  98041 -3003
Applicant Contact NANCY BURKE
Correspondent
Philips Medical Systems
22100 Bothell Everett Highway
Bothell,  WA  98041 -3003
Correspondent Contact NANCY BURKE
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
DPS   LDD   LIX  
Date Received03/13/2013
Decision Date 10/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-