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FDA 510(k)

CerroZone Mini

K-Number: K242102 · 2024-11-19

Decision Date2024-11-19
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CerroZone Mini is the device name listed in this FDA 510(k) record. The listed applicant is Cerrozone, LLC. It received FDA 510(k) clearance on 2024-11-19 under 510(k) number K242102. 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 Mini?

CerroZone Mini is a medical device that received FDA 510(k) clearance on 2024-11-19. The listed applicant is Cerrozone, LLC. The 510(k) number is K242102.

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

CerroZone Mini received FDA 510(k) clearance on 2024-11-19, under 510(k) number K242102.

Who is the listed applicant for CerroZone Mini?

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

What is the FDA product code for CerroZone Mini?

The FDA product code for CerroZone Mini is FRF.

Other records listing Cerrozone, LLC 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.

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.

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.