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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 K884765
Device Name CLINICAL ELECTRONIC THERMOMETERS
Applicant
Sheridan Catheter Corp.
Rte. 40
Argyle,  NY  12809
Applicant Contact STEEN, PH.D.
Correspondent
Sheridan Catheter Corp.
Rte. 40
Argyle,  NY  12809
Correspondent Contact STEEN, PH.D.
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/14/1988
Decision Date 02/16/1989
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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