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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 K112376
Device Name S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
Original Applicant
CIRCA SCIENTIFIC, LLC
14 inverness drive east,
suite h240
englewood,  CO  80112
Original Contact fred piazza
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/17/2011
Decision Date 08/31/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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