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FDA 510(k)

R-Sensor, R-Sensor

K-Number: K200284 · 2020-02-28

ApplicantRemedi Co., Ltd.
Decision Date2020-02-28
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R-Sensor, R-Sensor is a medical device manufactured by Remedi Co., Ltd.. It received FDA 510(k) clearance on 2020-02-28 under approval number K200284. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R-Sensor, R-Sensor?

R-Sensor, R-Sensor is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Remedi Co., Ltd.. The 510(k) number is K200284.

When was R-Sensor, R-Sensor approved by the FDA?

R-Sensor, R-Sensor received FDA 510(k) clearance on 2020-02-28, under approval number K200284.

What company makes R-Sensor, R-Sensor?

R-Sensor, R-Sensor is manufactured by Remedi Co., Ltd..

What is the FDA product code for R-Sensor, R-Sensor?

The FDA product code for R-Sensor, R-Sensor is MUH.

Other Devices by Remedi Co., Ltd.

K212144Remex KA6 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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