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FDA 510(k)

ULTIMATE-AIRE

K-Number: K813258 · 1982-02-05

ApplicantHawkins Intl.
Decision Date1982-02-05
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTIMATE-AIRE is the device name listed in this FDA 510(k) record. The listed applicant is Hawkins Intl.. It received FDA 510(k) clearance on 1982-02-05 under 510(k) number K813258. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMATE-AIRE?

ULTIMATE-AIRE is a medical device that received FDA 510(k) clearance on 1982-02-05. The listed applicant is Hawkins Intl.. The 510(k) number is K813258.

When did ULTIMATE-AIRE receive FDA 510(k) clearance?

ULTIMATE-AIRE received FDA 510(k) clearance on 1982-02-05, under 510(k) number K813258.

Who is the listed applicant for ULTIMATE-AIRE?

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

What is the FDA product code for ULTIMATE-AIRE?

The FDA product code for ULTIMATE-AIRE is FRF.

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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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