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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K001281
Device Name GERATHERM BABYWATCH TEMPERATURE MONITOR
Applicant
GERATHERM AG
2000 TOWN CENTER
SUITE 1900
SOUTHFIELD,  MI  48075 -2645
Applicant Contact ED HOLTER
Correspondent
GERATHERM AG
2000 TOWN CENTER
SUITE 1900
SOUTHFIELD,  MI  48075 -2645
Correspondent Contact ED HOLTER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/21/2000
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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