FDA 510(k) Application Details - K961060

Device Classification Name Stethoscope, Esophageal, With Electrical Conductors

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510(K) Number K961060
Device Name Stethoscope, Esophageal, With Electrical Conductors
Applicant ARISTO MEDICAL PRODUCTS, INC.
P.O. BOX 1637
WAUKESHA, WI 53187-2345 US
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Contact STEPHEN H GORSKI
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Regulation Number 868.1920

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Classification Product Code BZT
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Date Received 03/18/1996
Decision Date 06/19/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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