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FDA 510(k) Application Details - K072621
Device Classification Name
Stethoscope, Esophageal, With Electrical Conductors
More FDA Info for this Device
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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FATMA ALI
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Regulation Number
868.1920
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Classification Product Code
BZT
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More FDA Info for this Product Code
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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