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 K040775
Device Name LIFEPAK 12
Applicant
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD NE
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Applicant Contact MICHELLE ACKERMANN
Correspondent
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD NE
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Correspondent Contact MICHELLE ACKERMANN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received03/26/2004
Decision Date 04/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-