510(k) K841832
- Device
- GLOTTAL FREQUENCY ANALYSER
- Applicant
- Teltec Electronic Equipment AB
- 510(k) number
- K841832
- Product code
- KLX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-18
- Date received
- 1984-05-03
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2518897
- 1319182
Source Documents#
510(k) summary PDF not indicated by FDA