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FDA 510(k)

HEPA AIR CLEANER

K-Number: K940573 · 1994-08-25

ApplicantDuracraft Corp.
Decision Date1994-08-25
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEPA AIR CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Duracraft Corp.. It received FDA 510(k) clearance on 1994-08-25 under 510(k) number K940573. 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 HEPA AIR CLEANER?

HEPA AIR CLEANER is a medical device that received FDA 510(k) clearance on 1994-08-25. The listed applicant is Duracraft Corp.. The 510(k) number is K940573.

When did HEPA AIR CLEANER receive FDA 510(k) clearance?

HEPA AIR CLEANER received FDA 510(k) clearance on 1994-08-25, under 510(k) number K940573.

Who is the listed applicant for HEPA AIR CLEANER?

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

What is the FDA product code for HEPA AIR CLEANER?

The FDA product code for HEPA AIR CLEANER is FRF.

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Related Devices (Code: FRF)

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.

K251872Biomoneta Avata RxBiomoneta Research Private LimitedK242102CerroZone MiniCerrozone, LLCK240696Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd.K223835MA-40, MA-112Medify Air, LLCK222416RIA SafeguardRia Tech Co., Ltd.K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech , Ltd.

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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