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 K040404
Device Name HEARTSTART MRX, MODEL M3535A
Applicant
Philips Medical Systems, Inc.
3000 Minuteman Rd. Ms 0222
Andover,  MA  01810 -1099
Applicant Contact PETER OHANIAN
Correspondent
Philips Medical Systems, Inc.
3000 Minuteman Rd. Ms 0222
Andover,  MA  01810 -1099
Correspondent Contact PETER OHANIAN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/17/2004
Decision Date 05/04/2004
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
-
-