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FDA 510(k)

GEMS-H

K-Number: K213452 · 2022-04-21

ApplicantSamsung Electronics Co., Ltd.
Decision Date2022-04-21
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GEMS-H is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213452. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMS-H?

GEMS-H is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K213452.

When did GEMS-H receive FDA 510(k) clearance?

GEMS-H received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213452.

Who is the listed applicant for GEMS-H?

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

What is the FDA product code for GEMS-H?

The FDA product code for GEMS-H is PHL.

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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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