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, High Energy, (Including Paddles)
510(k) Number K934067
Device Name POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
Applicant
National Custom Ent., Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Applicant Contact MIKE BENYO
Correspondent
National Custom Ent., Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Correspondent Contact MIKE BENYO
Regulation Number870.5300
Classification Product Code
DRK  
Subsequent Product Code
DRX  
Date Received08/20/1993
Decision Date 10/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-