510(k) K823126

MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER by Electromedics, Inc. — Product Code BZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1982
Date Received
October 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Esophageal
Device Class
Class I
Regulation Number
868.1910
Review Panel
AN
Submission Type