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FDA 510(k)

BSD3543W

K-Number: K200787 · 2020-04-23

ApplicantBontech Co., Ltd.
Decision Date2020-04-23
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BSD3543W is a medical device manufactured by Bontech Co., Ltd.. It received FDA 510(k) clearance on 2020-04-23 under approval number K200787. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BSD3543W?

BSD3543W is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by Bontech Co., Ltd.. The 510(k) number is K200787.

When was BSD3543W approved by the FDA?

BSD3543W received FDA 510(k) clearance on 2020-04-23, under approval number K200787.

What company makes BSD3543W?

BSD3543W is manufactured by Bontech Co., Ltd..

What is the FDA product code for BSD3543W?

The FDA product code for BSD3543W is MQB.

Other Devices by Bontech Co., Ltd.

K243864BONX805

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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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