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FDA 510(k) Application Details - K961060
Device Classification Name
Stethoscope, Esophageal, With Electrical Conductors
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
STEPHEN H GORSKI
Other 510(k) Applications for this Contact
Regulation Number
868.1920
More FDA Info for this Regulation Number
Classification Product Code
BZT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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