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FDA 510(k)

EM-4000 Specular Microscope

K-Number: K171313 · 2018-01-19

Decision Date2018-01-19
Product CodeNQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EM-4000 Specular Microscope is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K171313. The device is classified under product code NQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EM-4000 Specular Microscope?

EM-4000 Specular Microscope is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Tomey Corporation. The 510(k) number is K171313.

When did EM-4000 Specular Microscope receive FDA 510(k) clearance?

EM-4000 Specular Microscope received FDA 510(k) clearance on 2018-01-19, under 510(k) number K171313.

Who is the listed applicant for EM-4000 Specular Microscope?

The FDA 510(k) record lists Tomey Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EM-4000 Specular Microscope?

The FDA product code for EM-4000 Specular Microscope is NQE.

Other records listing Tomey Corporation as applicant

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.

Related Devices (Code: NQE)

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.

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.