STEREO AUDITORY TRAINER (MODEL PM228)— 510(k) K810031

Name: FDA 510(k) clearance K810031
Creator: U.S. Food and Drug Administration
Published: 1981-03-04

Substantially Equivalent

Hc Electronics

FDA 510(k) clearance K810031 for STEREO AUDITORY TRAINER (MODEL PM228), Substantially Equivalent on 1981-03-04. Applicant: Hc Electronics. Device class: 2.

Clearance details

Applicant: Hc Electronics
Product code: Code EPF
Device class: Class 2
Regulation: 21 CFR 874.3320
Advisory panel: Ear, Nose, Throat
Date received: 1981-01-06
Decision date: 1981-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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