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FDA 510(k)

BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER

K-Number: K942434 · 1994-12-14

ApplicantBionaire Corp.
Decision Date1994-12-14
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER is the device name listed in this FDA 510(k) record. The listed applicant is Bionaire Corp.. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K942434. 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 BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER?

BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Bionaire Corp.. The 510(k) number is K942434.

When did BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER receive FDA 510(k) clearance?

BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER received FDA 510(k) clearance on 1994-12-14, under 510(k) number K942434.

Who is the listed applicant for BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER?

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

What is the FDA product code for BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER?

The FDA product code for BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER is FRF.

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.

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Other records listing Bionaire Corp. as applicant

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.

K942683BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550

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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