510(k) K901609

ELECTROGLOTTOGRAPH by Glottal Ent., Inc. — Product Code KLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1990
Date Received
April 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electroglottograph
Device Class
Class II
Regulation Number
874.1325
Review Panel
EN
Submission Type