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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Rd.
Sharonville,  OH  45241
Applicant Contact FATMA ALI
Correspondent
Cincinnati Sub-Zero Products, Inc.
12011 Mosteller Rd.
Sharonville,  OH  45241
Correspondent Contact FATMA ALI
Regulation Number868.1920
Classification Product Code
BZT  
Date Received09/17/2007
Decision Date 12/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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