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FDA 510(k)

Smart Peak Flow Meter

K-Number: K191239 · 2019-12-06

ApplicantGuangzhou Homesun Medical Technology Co., Ltd.
Decision Date2019-12-06
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Smart Peak Flow Meter is a medical device manufactured by Guangzhou Homesun Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-06 under approval number K191239. 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 Peak Flow Meter?

Smart Peak Flow Meter is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Guangzhou Homesun Medical Technology Co., Ltd.. The 510(k) number is K191239.

When was Smart Peak Flow Meter approved by the FDA?

Smart Peak Flow Meter received FDA 510(k) clearance on 2019-12-06, under approval number K191239.

What company makes Smart Peak Flow Meter?

Smart Peak Flow Meter is manufactured by Guangzhou Homesun Medical Technology Co., Ltd..

What is the FDA product code for Smart Peak Flow Meter?

The FDA product code for Smart Peak Flow Meter is BZH.

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Other Devices by Guangzhou Homesun Medical Technology Co., Ltd.

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Related Devices (Code: BZH)

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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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