ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR


Device Classification Name

stethoscope, esophageal, with electrical conductors

510(k) Number K111050
Device Name ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
Applicant
STARBOARD MEDICAL, LLC
22845 savi ranch pkwy
suite h
yorba linda, 
CA 
92887

Applicant Contact anthony beran
Correspondent
STARBOARD MEDICAL, LLC
22845 savi ranch pkwy
suite h
yorba linda, 
CA 
92887

Correspodent Contact anthony beran
Regulation Number 868.1920
Classification Product Code
BZT  
Date Received 04/15/2011
Decision Date 04/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No