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FDA 510(k)

F/LS MCA APPLICATION SOFTWARE

K-Number: K801456 · 1980-10-03

ApplicantInstrumentation Laboratory CO
Decision Date1980-10-03
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

F/LS MCA APPLICATION SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1980-10-03 under 510(k) number K801456. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F/LS MCA APPLICATION SOFTWARE?

F/LS MCA APPLICATION SOFTWARE is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K801456.

When did F/LS MCA APPLICATION SOFTWARE receive FDA 510(k) clearance?

F/LS MCA APPLICATION SOFTWARE received FDA 510(k) clearance on 1980-10-03, under 510(k) number K801456.

Who is the listed applicant for F/LS MCA APPLICATION SOFTWARE?

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

What is the FDA product code for F/LS MCA APPLICATION SOFTWARE?

The FDA product code for F/LS MCA APPLICATION SOFTWARE is CFR.

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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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