MODULE PERSONAL EAR (DELUXE)— 510(k) K790095

Substantially Equivalent

Qualitone

FDA 510(k) clearance K790095 for MODULE PERSONAL EAR (DELUXE), Substantially Equivalent on 1979-01-26. Applicant: Qualitone. Device class: 1.

Clearance details

Applicant
Qualitone
Product code
Code ESD
Device class
Class 1
Regulation
21 CFR 874.3300
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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