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FDA 510(k)

BONX805

K-Number: K243864 · 2025-09-12

ApplicantBontech Co., Ltd.
Decision Date2025-09-12
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BONX805 is a medical device manufactured by Bontech Co., Ltd.. It received FDA 510(k) clearance on 2025-09-12 under approval number K243864. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONX805?

BONX805 is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Bontech Co., Ltd.. The 510(k) number is K243864.

When was BONX805 approved by the FDA?

BONX805 received FDA 510(k) clearance on 2025-09-12, under approval number K243864.

What company makes BONX805?

BONX805 is manufactured by Bontech Co., Ltd..

What is the FDA product code for BONX805?

The FDA product code for BONX805 is IZL.

Other Devices by Bontech Co., Ltd.

K200787BSD3543W

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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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