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FDA 510(k)

REMEX-GR100

K-Number: K240759 · 2024-05-13

Decision Date2024-05-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMEX-GR100 is the device name listed in this FDA 510(k) record. The listed applicant is Remedi Co., Ltd.. It received FDA 510(k) clearance on 2024-05-13 under 510(k) 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. The listed applicant is Remedi Co., Ltd.. The 510(k) number is K240759.

When did REMEX-GR100 receive FDA 510(k) clearance?

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

Who is the listed applicant for REMEX-GR100?

The FDA 510(k) record lists Remedi Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMEX-GR100?

The FDA product code for REMEX-GR100 is EHD.

Other records listing Remedi Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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