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FDA 510(k)

POLLENEX HEPA AIR CLEANERS

K-Number: K925055 · 1994-05-18

ApplicantPollenex Corp.
Decision Date1994-05-18
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLLENEX HEPA AIR CLEANERS is the device name listed in this FDA 510(k) record. The listed applicant is Pollenex Corp.. It received FDA 510(k) clearance on 1994-05-18 under 510(k) number K925055. 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 POLLENEX HEPA AIR CLEANERS?

POLLENEX HEPA AIR CLEANERS is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is Pollenex Corp.. The 510(k) number is K925055.

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

POLLENEX HEPA AIR CLEANERS received FDA 510(k) clearance on 1994-05-18, under 510(k) number K925055.

Who is the listed applicant for POLLENEX HEPA AIR CLEANERS?

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

What is the FDA product code for POLLENEX HEPA AIR CLEANERS?

The FDA product code for POLLENEX HEPA AIR CLEANERS 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 Pollenex 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.

K925907AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER

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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