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510(k) K901609

Device
ELECTROGLOTTOGRAPH
Applicant
GLOTTAL ENT., INC.
510(k) number
K901609
Product code
KLX  
Decision
Substantially Equivalent (SESE)
Decision date
1990-06-28
Date received
1990-04-06
Regulation
874.1325
Classification name
Electroglottograph
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
& JAWORSKI
Address
Suite 400 1150 Connecticut Ave., NW Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KLX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990240ELECTROGLOTTOGRAPHKay Elemetrics Corp.1999-03-11
K841832GLOTTAL FREQUENCY ANALYSERTeltec Electronic Equipment AB1984-07-18
K821079ELECTROGLOTTOGRAPH NAKED EGG BOXED EGGMs. Kate Teaney1982-05-10

Legacy Summary#

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FDA Review#

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