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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, infant radiant
510(k) Number K970432
Device Name INFANT RADIANT WARMER - MODELS IW910 AND IW920
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 Received02/04/1997
Decision Date 05/07/1997
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
Recalls CDRH Recalls
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