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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K902386
Device Name MODEL TM101 TEMPERATURE MONITOR
Applicant
Fisher & Paykel Electronics , Ltd.
25 Carbine Rd. Panmure
P.O. Box 14 348 Panmure
Auckland, New Zealand,  NZ
Applicant Contact RICHARD BELGRAVE
Correspondent
Fisher & Paykel Electronics , Ltd.
25 Carbine Rd. Panmure
P.O. Box 14 348 Panmure
Auckland, New Zealand,  NZ
Correspondent Contact RICHARD BELGRAVE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/30/1990
Decision Date 01/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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