• 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 K022732
Device Name INFANT/CHILD REDUCED ENERGY ELECTRODES
Applicant
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD., N.E.
redmond,  WA  98073
Applicant Contact sherri l pocock
Correspondent
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD., N.E.
redmond,  WA  98073
Correspondent Contact sherri l pocock
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received08/16/2002
Decision Date 12/13/2002
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
-
-