510(k) K830173

BERA SH 221 BRIAN STEM AUDIOMETER by Jedmed Instrument Co. — Product Code GNJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1983
Date Received
January 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Echovirus 1-34
Device Class
Class I
Regulation Number
866.3205
Review Panel
MI
Submission Type