FALCK APPLANATION TONOMETER (FAT2)— 510(k) K071755

Name: FDA 510(k) clearance K071755
Creator: U.S. Food and Drug Administration
Published: 2008-06-03

Substantially Equivalent

Falck Medical, Inc.

FDA 510(k) clearance K071755 for FALCK APPLANATION TONOMETER (FAT2), Substantially Equivalent on 2008-06-03. Applicant: Falck Medical, Inc.. Device class: 2.

Clearance details

Applicant: Falck Medical, Inc.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2007-06-28
Decision date: 2008-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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