510(k) K982193

ESOPHAGEAL STETHOSCOPE by Shore Medical, Inc. — Product Code BZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1998
Date Received
June 22, 1998
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