510(k) K880917

LYTENING 5 by Amdev, Inc. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1988
Date Received
March 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type