PERSONAL AMPLIFIER MODEL ULTRA HELIX— 510(k) K893433

Substantially Equivalent

Electone, Inc.

FDA 510(k) clearance K893433 for PERSONAL AMPLIFIER MODEL ULTRA HELIX, Substantially Equivalent on 1989-06-14. Applicant: Electone, Inc..

Clearance details

Applicant
Electone, Inc.
Product code
Code ESD
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Winter Park, FL, US
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