EM-4000 Specular Microscope
K-Number: K171313 · 2018-01-19
ApplicantTomey Corporation
Decision Date2018-01-19
Product CodeNQE
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
EM-4000 Specular Microscope is a medical device manufactured by Tomey Corporation. It received FDA 510(k) clearance on 2018-01-19 under approval 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. It is manufactured by Tomey Corporation. The 510(k) number is K171313.
When was EM-4000 Specular Microscope approved by the FDA?
EM-4000 Specular Microscope received FDA 510(k) clearance on 2018-01-19, under approval number K171313.
What company makes EM-4000 Specular Microscope?
EM-4000 Specular Microscope is manufactured by Tomey Corporation.
What is the FDA product code for EM-4000 Specular Microscope?
The FDA product code for EM-4000 Specular Microscope is NQE.
Other Devices by Tomey Corporation
Related Devices (Code: NQE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.