ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR


Device Classification Name

stethoscope, esophageal, with electrical conductors

510(k) Number K072621
Device Name ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
Applicant
CINCINNATI SUB-ZERO PRODUCTS, INC
12011 mosteller road
cincinnati, 
OH 
45241

Applicant Contact fatma ali
Correspondent
CINCINNATI SUB-ZERO PRODUCTS, INC
12011 mosteller road
cincinnati, 
OH 
45241

Correspodent Contact fatma ali
Regulation Number 868.1920
Classification Product Code
BZT  
Date Received 09/17/2007
Decision Date 12/13/2007
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

Recalls CDRH Recalls