S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM


Device Classification Name

thermometer, electronic, clinical

510(k) Number K112376
Device Name S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
Applicant
CIRCA SCIENTIFIC, LLC
14 inverness drive east,
suite h240
englewood, 
CO 
80112

Applicant Contact fred piazza
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 08/17/2011
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