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 Warmer, Infant Radiant
510(k) Number K972885
Device Name SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
Applicant
Fisher & Paykel Electronics , Ltd.
Healthcare Div.
25 Carbine Rd., P.O. Box 14348
Auckland,  NZ
Applicant Contact CHRIS MANDER
Correspondent
Fisher & Paykel Electronics , Ltd.
Healthcare Div.
25 Carbine Rd., P.O. Box 14348
Auckland,  NZ
Correspondent Contact CHRIS MANDER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received08/05/1997
Decision Date 10/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-