ELECTROGLOTTOGRAPH

Electroglottograph

GLOTTAL ENT., INC.

The following data is part of a premarket notification filed by Glottal Ent., Inc. with the FDA for Electroglottograph.

Pre-market Notification Details

Device IDK901609
510k NumberK901609
Device Name:ELECTROGLOTTOGRAPH
ClassificationElectroglottograph
Applicant GLOTTAL ENT., INC. SUITE 400 1150 CONNECTICUT AVENUE, N.W. Washington,  DC  20036
Contact& Jaworski
Correspondent& Jaworski
GLOTTAL ENT., INC. SUITE 400 1150 CONNECTICUT AVENUE, N.W. Washington,  DC  20036
Product CodeKLX  
CFR Regulation Number874.1325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-06
Decision Date1990-06-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860011116905 K901609 000

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