FDA 510(k)

Smart One

K-Number: K181666 · 2018-08-01

ApplicantMir Medical International Research

Decision Date2018-08-01

Product CodeBZH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Smart One is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical International Research. It received FDA 510(k) clearance on 2018-08-01 under 510(k) number K181666. 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 Smart One?

Smart One is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Mir Medical International Research. The 510(k) number is K181666.

When did Smart One receive FDA 510(k) clearance?

Smart One received FDA 510(k) clearance on 2018-08-01, under 510(k) number K181666.

Who is the listed applicant for Smart One?

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

What is the FDA product code for Smart One?

The FDA product code for Smart One is BZH.

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.

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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.