OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER— 510(k) K030393

Name: FDA 510(k) clearance K030393
Creator: U.S. Food and Drug Administration
Published: 2003-09-25

Substantially Equivalent

Haag-Streit Holding AG

FDA 510(k) clearance K030393 for OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER, Substantially Equivalent on 2003-09-25. Applicant: Haag-Streit Holding AG. Device class: 2.

Clearance details

Applicant: Haag-Streit Holding AG
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2003-02-05
Decision date: 2003-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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