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FDA 510(k)

REMEX-GR100

K-Number: K240759 · 2024-05-13

ApplicantRemedi Co., Ltd.
Decision Date2024-05-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMEX-GR100 is a medical device manufactured by Remedi Co., Ltd.. It received FDA 510(k) clearance on 2024-05-13 under approval number K240759. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEX-GR100?

REMEX-GR100 is a medical device that received FDA 510(k) clearance on 2024-05-13. It is manufactured by Remedi Co., Ltd.. The 510(k) number is K240759.

When was REMEX-GR100 approved by the FDA?

REMEX-GR100 received FDA 510(k) clearance on 2024-05-13, under approval number K240759.

What company makes REMEX-GR100?

REMEX-GR100 is manufactured by Remedi Co., Ltd..

What is the FDA product code for REMEX-GR100?

The FDA product code for REMEX-GR100 is EHD.

Other Devices by Remedi Co., Ltd.

K200284R-Sensor, R-Sensor K212144Remex KA6

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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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