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FDA 510(k)

MA-40, MA-112

K-Number: K223835 · 2023-09-18

ApplicantMedify Air, LLC
Decision Date2023-09-18
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MA-40, MA-112 is the device name listed in this FDA 510(k) record. The listed applicant is Medify Air, LLC. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K223835. 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 MA-40, MA-112?

MA-40, MA-112 is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is Medify Air, LLC. The 510(k) number is K223835.

When did MA-40, MA-112 receive FDA 510(k) clearance?

MA-40, MA-112 received FDA 510(k) clearance on 2023-09-18, under 510(k) number K223835.

Who is the listed applicant for MA-40, MA-112?

The FDA 510(k) record lists Medify Air, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MA-40, MA-112?

The FDA product code for MA-40, MA-112 is FRF.

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.K222416RIA SafeguardRia Tech Co., Ltd.K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech , Ltd.K220990Qorda QD1Winix, Inc.

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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