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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 K896779
Device Name CT-1000A SYSTEM
Applicant
Bio-Monitor, Inc.
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Bio-Monitor, Inc.
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/01/1989
Decision Date 06/01/1990
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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