FDA 510(k)

OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER

K-Number: K030393 · 2003-09-25

Decision Date2003-09-25

Product CodeMXK

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER is the device name listed in this FDA 510(k) record. The listed applicant is Haag-Streit Holding AG. It received FDA 510(k) clearance on 2003-09-25 under 510(k) number K030393. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER?

OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER is a medical device that received FDA 510(k) clearance on 2003-09-25. The listed applicant is Haag-Streit Holding AG. The 510(k) number is K030393.

When did OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER receive FDA 510(k) clearance?

OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER received FDA 510(k) clearance on 2003-09-25, under 510(k) number K030393.

Who is the listed applicant for OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER?

The FDA 510(k) record lists Haag-Streit Holding AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER?

The FDA product code for OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER is MXK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.