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FDA 510(k)

CerroZone Mobile

K-Number: K220298 · 2022-07-01

ApplicantCerrozone
Decision Date2022-07-01
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CerroZone Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Cerrozone. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K220298. 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 CerroZone Mobile?

CerroZone Mobile is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Cerrozone. The 510(k) number is K220298.

When did CerroZone Mobile receive FDA 510(k) clearance?

CerroZone Mobile received FDA 510(k) clearance on 2022-07-01, under 510(k) number K220298.

Who is the listed applicant for CerroZone Mobile?

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

What is the FDA product code for CerroZone Mobile?

The FDA product code for CerroZone Mobile is FRF.

Other records listing Cerrozone 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.

K242102CerroZone Mini

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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