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FDA 510(k)

MARK III

K-Number: K800663 · 1980-04-08

ApplicantApplied Science Laboratories
Decision Date1980-04-08
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MARK III is the device name listed in this FDA 510(k) record. The listed applicant is Applied Science Laboratories. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800663. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK III?

MARK III is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is Applied Science Laboratories. The 510(k) number is K800663.

When did MARK III receive FDA 510(k) clearance?

MARK III received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800663.

Who is the listed applicant for MARK III?

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

What is the FDA product code for MARK III?

The FDA product code for MARK III is DXN.

Other records listing Applied Science Laboratories 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.

K800661MODEL S/D-600 AUTO INFLATE CONTROL MODULK800662MARK II

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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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