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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 K000969
Device Name MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1
Applicant
MICROLIFE CORP.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
MICROLIFE CORP.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/27/2000
Decision Date 08/22/2000
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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