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FDA 510(k)

MODEL 450 INFRARED IMAGING SYSTEM

K-Number: K861534 · 1986-07-18

ApplicantMitek , Inc.
Decision Date1986-07-18
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODEL 450 INFRARED IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mitek , Inc.. It received FDA 510(k) clearance on 1986-07-18 under 510(k) number K861534. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MODEL 450 INFRARED IMAGING SYSTEM?

MODEL 450 INFRARED IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Mitek , Inc.. The 510(k) number is K861534.

When did MODEL 450 INFRARED IMAGING SYSTEM receive FDA 510(k) clearance?

MODEL 450 INFRARED IMAGING SYSTEM received FDA 510(k) clearance on 1986-07-18, under 510(k) number K861534.

Who is the listed applicant for MODEL 450 INFRARED IMAGING SYSTEM?

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

What is the FDA product code for MODEL 450 INFRARED IMAGING SYSTEM?

The FDA product code for MODEL 450 INFRARED IMAGING SYSTEM is LHQ.

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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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