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FDA 510(k)

CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE

K-Number: K112880 · 2013-01-31

ApplicantFreedom Meditech, Inc.
Decision Date2013-01-31
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Meditech, Inc.. It received FDA 510(k) clearance on 2013-01-31 under 510(k) number K112880. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE?

CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE is a medical device that received FDA 510(k) clearance on 2013-01-31. The listed applicant is Freedom Meditech, Inc.. The 510(k) number is K112880.

When did CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE receive FDA 510(k) clearance?

CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE received FDA 510(k) clearance on 2013-01-31, under 510(k) number K112880.

Who is the listed applicant for CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE?

The FDA 510(k) record lists Freedom Meditech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE?

The FDA product code for CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE is MYC.

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Related Devices (Code: MYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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