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FDA 510(k)

GR40CW

K-Number: K181631 · 2018-07-20

ApplicantSamsung Electronics Co., Ltd.
Decision Date2018-07-20
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GR40CW 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 2018-07-20 under 510(k) number K181631. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GR40CW?

GR40CW is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K181631.

When did GR40CW receive FDA 510(k) clearance?

GR40CW received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181631.

Who is the listed applicant for GR40CW?

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 GR40CW?

The FDA product code for GR40CW is MQB.

Other records listing Samsung Electronics Co., Ltd. as applicant

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Related Devices (Code: MQB)

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.

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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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