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FDA 510(k)

HYGIENIC AIR PURIFYING DEVICE

K-Number: K861299 · 1986-07-23

ApplicantPuridyne, Inc./Imutech, Inc.
Decision Date1986-07-23
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

HYGIENIC AIR PURIFYING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Puridyne, Inc./Imutech, Inc.. It received FDA 510(k) clearance on 1986-07-23 under 510(k) number K861299. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HYGIENIC AIR PURIFYING DEVICE?

HYGIENIC AIR PURIFYING DEVICE is a medical device that received FDA 510(k) clearance on 1986-07-23. The listed applicant is Puridyne, Inc./Imutech, Inc.. The 510(k) number is K861299.

When did HYGIENIC AIR PURIFYING DEVICE receive FDA 510(k) clearance?

HYGIENIC AIR PURIFYING DEVICE received FDA 510(k) clearance on 1986-07-23, under 510(k) number K861299.

Who is the listed applicant for HYGIENIC AIR PURIFYING DEVICE?

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

What is the FDA product code for HYGIENIC AIR PURIFYING DEVICE?

The FDA product code for HYGIENIC AIR PURIFYING DEVICE 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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