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FDA 510(k)

RXAIR 3000

K-Number: K951981 · 1995-10-12

ApplicantClean Air Research & Development
Decision Date1995-10-12
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RXAIR 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Clean Air Research & Development. It received FDA 510(k) clearance on 1995-10-12 under 510(k) number K951981. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RXAIR 3000?

RXAIR 3000 is a medical device that received FDA 510(k) clearance on 1995-10-12. The listed applicant is Clean Air Research & Development. The 510(k) number is K951981.

When did RXAIR 3000 receive FDA 510(k) clearance?

RXAIR 3000 received FDA 510(k) clearance on 1995-10-12, under 510(k) number K951981.

Who is the listed applicant for RXAIR 3000?

The FDA 510(k) record lists Clean Air Research & Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RXAIR 3000?

The FDA product code for RXAIR 3000 is FRA.

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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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