FDA 510(k) Application Details - K072621

Device Classification Name Stethoscope, Esophageal, With Electrical Conductors

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510(K) Number K072621
Device Name Stethoscope, Esophageal, With Electrical Conductors
Applicant CINCINNATI SUB-ZERO PRODUCTS, INC
12011 MOSTELLER ROAD
CINCINNATI, OH 45241 US
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Contact FATMA ALI
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Regulation Number 868.1920

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Classification Product Code BZT
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Date Received 09/17/2007
Decision Date 12/13/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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