Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Mir Medical International Research. It received FDA 510(k) clearance on 2018-08-01 under approval 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. It is manufactured by Mir Medical International Research. The 510(k) number is K181666.

When was Smart One approved by the FDA?

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

What company makes Smart One?

Smart One is manufactured by Mir Medical International Research.

What is the FDA product code for Smart One?

The FDA product code for Smart One is BZH.

Related Devices (Code: BZH)

K152276Wing Smart FEVI and Peak Flow MeterSparo, Inc. K170281MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd. K180487Peak.meBreathe Me, Ltd. K172804Besmed Peak Flow MeterBesmed Health Business Corp K191239Smart Peak Flow MeterGuangzhou Homesun Medical Technology Co., Ltd. K200832Safey Peak Flow MeterSafey Medical Devices Pvt, 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.

↑