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FDA 510(k)

Remex KA6

K-Number: K212144 · 2021-08-03

ApplicantRemedi Co., Ltd.
Decision Date2021-08-03
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Remex KA6 is a medical device manufactured by Remedi Co., Ltd.. It received FDA 510(k) clearance on 2021-08-03 under approval number K212144. 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 Remex KA6?

Remex KA6 is a medical device that received FDA 510(k) clearance on 2021-08-03. It is manufactured by Remedi Co., Ltd.. The 510(k) number is K212144.

When was Remex KA6 approved by the FDA?

Remex KA6 received FDA 510(k) clearance on 2021-08-03, under approval number K212144.

What company makes Remex KA6?

Remex KA6 is manufactured by Remedi Co., Ltd..

What is the FDA product code for Remex KA6?

The FDA product code for Remex KA6 is IZL.

Other Devices by Remedi Co., Ltd.

K200284R-Sensor, R-Sensor K240759REMEX-GR100

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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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