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FDA 510(k)

INFRA-EYE 160

K-Number: K841271 · 1984-07-28

ApplicantFujitsu , Ltd.
Decision Date1984-07-28
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INFRA-EYE 160 is the device name listed in this FDA 510(k) record. The listed applicant is Fujitsu , Ltd.. It received FDA 510(k) clearance on 1984-07-28 under 510(k) number K841271. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFRA-EYE 160?

INFRA-EYE 160 is a medical device that received FDA 510(k) clearance on 1984-07-28. The listed applicant is Fujitsu , Ltd.. The 510(k) number is K841271.

When did INFRA-EYE 160 receive FDA 510(k) clearance?

INFRA-EYE 160 received FDA 510(k) clearance on 1984-07-28, under 510(k) number K841271.

Who is the listed applicant for INFRA-EYE 160?

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

What is the FDA product code for INFRA-EYE 160?

The FDA product code for INFRA-EYE 160 is LHQ.

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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.

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