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FDA 510(k)

ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P

K-Number: K052732 · 2006-02-24

Decision Date2006-02-24
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P is the device name listed in this FDA 510(k) record. The listed applicant is Abracair, Inc.. It received FDA 510(k) clearance on 2006-02-24 under 510(k) number K052732. 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 ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P?

ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P is a medical device that received FDA 510(k) clearance on 2006-02-24. The listed applicant is Abracair, Inc.. The 510(k) number is K052732.

When did ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P receive FDA 510(k) clearance?

ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P received FDA 510(k) clearance on 2006-02-24, under 510(k) number K052732.

Who is the listed applicant for ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P?

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

What is the FDA product code for ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P?

The FDA product code for ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P is FRA.

Related Clinical Trials

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.

Related Devices (Code: FRA)

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.

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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