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 System, Thermal Regulating
510(k) Number K952329
Device Name LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM
Applicant
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Applicant Contact WILLIAM F LOHNESS
Correspondent
Progressive Dynamics, Inc.
507 Industrial Rd.
Marshall,  MI  49068
Correspondent Contact WILLIAM F LOHNESS
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received05/18/1995
Decision Date 01/17/1996
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
-
-