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FDA 510(k)

Diode Laser System GP900A8, Diode Laser System GP900Q8

K-Number: K213225 · 2021-12-22

ApplicantShenzhen Gsd Tech Co., Ltd.
Decision Date2021-12-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser System GP900A8, Diode Laser System GP900Q8 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213225. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diode Laser System GP900A8, Diode Laser System GP900Q8?

Diode Laser System GP900A8, Diode Laser System GP900Q8 is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K213225.

When did Diode Laser System GP900A8, Diode Laser System GP900Q8 receive FDA 510(k) clearance?

Diode Laser System GP900A8, Diode Laser System GP900Q8 received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213225.

Who is the listed applicant for Diode Laser System GP900A8, Diode Laser System GP900Q8?

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

What is the FDA product code for Diode Laser System GP900A8, Diode Laser System GP900Q8?

The FDA product code for Diode Laser System GP900A8, Diode Laser System GP900Q8 is GEX. This falls under the Gastroenterology category.

Other records listing Shenzhen Gsd Tech Co., Ltd. as applicant

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Related Devices (Code: GEX)

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

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