510(k) K940169

DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE by Deroyal Industries, Inc. — Product Code BZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1994
Date Received
January 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Esophageal, With Electrical Conductors
Device Class
Class II
Regulation Number
868.1920
Review Panel
AN
Submission Type