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FDA 510(k)

MGA 2000 GAS ANALYSER

K-Number: K854076 · 1985-12-11

ApplicantAirspec , Ltd.
Decision Date1985-12-11
Product CodeDOP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MGA 2000 GAS ANALYSER is the device name listed in this FDA 510(k) record. The listed applicant is Airspec , Ltd.. It received FDA 510(k) clearance on 1985-12-11 under 510(k) number K854076. The device is classified under product code DOP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MGA 2000 GAS ANALYSER?

MGA 2000 GAS ANALYSER is a medical device that received FDA 510(k) clearance on 1985-12-11. The listed applicant is Airspec , Ltd.. The 510(k) number is K854076.

When did MGA 2000 GAS ANALYSER receive FDA 510(k) clearance?

MGA 2000 GAS ANALYSER received FDA 510(k) clearance on 1985-12-11, under 510(k) number K854076.

Who is the listed applicant for MGA 2000 GAS ANALYSER?

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

What is the FDA product code for MGA 2000 GAS ANALYSER?

The FDA product code for MGA 2000 GAS ANALYSER is DOP.

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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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