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FDA 510(k)

ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM

K-Number: K012549 · 2002-02-04

ApplicantHealthway Products, Inc.
Decision Date2002-02-04
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthway Products, Inc.. It received FDA 510(k) clearance on 2002-02-04 under 510(k) number K012549. 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 ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM?

ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-04. The listed applicant is Healthway Products, Inc.. The 510(k) number is K012549.

When did ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM receive FDA 510(k) clearance?

ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM received FDA 510(k) clearance on 2002-02-04, under 510(k) number K012549.

Who is the listed applicant for ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM?

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

What is the FDA product code for ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM?

The FDA product code for ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM 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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