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 Box, Battery, Rechargeable
510(k) Number K946080
Device Name PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
Applicant
Portable Power Systems, Inc.
1940 Tee Ln.
Castle Rock,  CO  80104
Applicant Contact NORMAN A PREMOP
Correspondent
Portable Power Systems, Inc.
1940 Tee Ln.
Castle Rock,  CO  80104
Correspondent Contact NORMAN A PREMOP
Regulation Number876.1500
Classification Product Code
FCO  
Date Received12/13/1994
Decision Date 08/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-