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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 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
Predetermined Change
Control Plan Authorized		 No
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