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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 K971461
Device Name SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
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 Received04/21/1997
Decision Date 07/16/1997
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
Recalls CDRH Recalls
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