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FDA 510(k)

Aluna 2

K-Number: K232588 · 2024-11-25

ApplicantKnox Medical Diagnostics
Decision Date2024-11-25
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Aluna 2 is the device name listed in this FDA 510(k) record. The listed applicant is Knox Medical Diagnostics. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K232588. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aluna 2?

Aluna 2 is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Knox Medical Diagnostics. The 510(k) number is K232588.

When did Aluna 2 receive FDA 510(k) clearance?

Aluna 2 received FDA 510(k) clearance on 2024-11-25, under 510(k) number K232588.

Who is the listed applicant for Aluna 2?

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

What is the FDA product code for Aluna 2?

The FDA product code for Aluna 2 is BZH.

Other records listing Knox Medical Diagnostics 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.

K193311Aluna

Related Devices (Code: BZH)

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.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife CorporationK252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar Co., Ltd.K203196Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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