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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 a medical device manufactured by Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-12-22 under approval 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. It is manufactured by Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K213225.

When was Diode Laser System GP900A8, Diode Laser System GP900Q8 approved by the FDA?

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

What company makes Diode Laser System GP900A8, Diode Laser System GP900Q8?

Diode Laser System GP900A8, Diode Laser System GP900Q8 is manufactured by Shenzhen Gsd Tech Co., Ltd..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Shenzhen Gsd Tech Co., Ltd.

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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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