UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)— 510(k) K964508

Name: FDA 510(k) clearance K964508
Creator: U.S. Food and Drug Administration
Published: 1996-11-27

Substantially Equivalent

Unitron Industries, Inc.

FDA 510(k) clearance K964508 for UNITRON MODEL ICON AOHP +4 (ICON AOHP +4), Substantially Equivalent on 1996-11-27. Applicant: Unitron Industries, Inc.. Device class: 1.

Clearance details

Applicant: Unitron Industries, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1996-11-08
Decision date: 1996-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

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