510(k) K990240

ELECTROGLOTTOGRAPH by Kay Elemetrics Corp. — Product Code KLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1999
Date Received
January 25, 1999
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