510(k) K841832

GLOTTAL FREQUENCY ANALYSER by Teltec Electronic Equipment AB — Product Code KLX

K841832 is an FDA 510(k) premarket notification submitted by Teltec Electronic Equipment AB for the device "GLOTTAL FREQUENCY ANALYSER". The FDA issued a decision of Substantially Equivalent on July 18, 1984. The device falls under product code KLX (Electroglottograph), a Class II device regulated under 21 CFR 874.1325.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1984
Date Received
May 3, 1984
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