FDA 510(k)

Aluna

K-Number: K193311 · 2020-03-25

Decision Date2020-03-25

Product CodeBZH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Aluna is the device name listed in this FDA 510(k) record. The listed applicant is Knox Medical Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K193311. 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?

Aluna is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Knox Medical Diagnostics, Inc.. The 510(k) number is K193311.

When did Aluna receive FDA 510(k) clearance?

Aluna received FDA 510(k) clearance on 2020-03-25, under 510(k) number K193311.

Who is the listed applicant for Aluna?

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

What is the FDA product code for Aluna?

The FDA product code for Aluna is BZH.

Other records listing Knox Medical Diagnostics, Inc. 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.

K232588Aluna 2

Related Devices (Code: BZH)

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical Diagnostics K230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar Co., 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.