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 Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K012274
Device Name MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
Applicant
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD NE
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Applicant Contact SHERRI L POCOCK
Correspondent
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD NE
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Correspondent Contact SHERRI L POCOCK
Regulation Number870.5300
Classification Product Code
LDD  
Date Received07/19/2001
Decision Date 02/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-