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 K971695
Device Name SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
Applicant
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE RD.
AUCKLAND,  NZ
Applicant Contact CHRIS MANDER
Correspondent
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE RD.
AUCKLAND,  NZ
Correspondent Contact CHRIS MANDER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received05/08/1997
Decision Date 07/28/1997
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
-
-