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FDA 510(k)

ROOM AIR PURIFIER (TEX-DYN)

K-Number: K760879 · 1976-12-16

ApplicantTexas Dynamics
Decision Date1976-12-16
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ROOM AIR PURIFIER (TEX-DYN) is the device name listed in this FDA 510(k) record. The listed applicant is Texas Dynamics. It received FDA 510(k) clearance on 1976-12-16 under 510(k) number K760879. 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 ROOM AIR PURIFIER (TEX-DYN)?

ROOM AIR PURIFIER (TEX-DYN) is a medical device that received FDA 510(k) clearance on 1976-12-16. The listed applicant is Texas Dynamics. The 510(k) number is K760879.

When did ROOM AIR PURIFIER (TEX-DYN) receive FDA 510(k) clearance?

ROOM AIR PURIFIER (TEX-DYN) received FDA 510(k) clearance on 1976-12-16, under 510(k) number K760879.

Who is the listed applicant for ROOM AIR PURIFIER (TEX-DYN)?

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

What is the FDA product code for ROOM AIR PURIFIER (TEX-DYN)?

The FDA product code for ROOM AIR PURIFIER (TEX-DYN) 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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