PANORET, MODEL PNM 60— 510(k) K040325

Name: FDA 510(k) clearance K040325
Creator: U.S. Food and Drug Administration
Published: 2004-03-08

Substantially Equivalent

Medibell Medical Vision Technologies , Ltd.

FDA 510(k) clearance K040325 for PANORET, MODEL PNM 60, Substantially Equivalent on 2004-03-08. Applicant: Medibell Medical Vision Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Medibell Medical Vision Technologies , Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2004-02-10
Decision date: 2004-03-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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