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FDA 510(k)

Oxylight

K-Number: K200104 · 2020-06-04

ApplicantRaja Trading Company, Inc.
Decision Date2020-06-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Oxylight is the device name listed in this FDA 510(k) record. The listed applicant is Raja Trading Company, Inc.. It received FDA 510(k) clearance on 2020-06-04 under 510(k) number K200104. 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 Oxylight?

Oxylight is a medical device that received FDA 510(k) clearance on 2020-06-04. The listed applicant is Raja Trading Company, Inc.. The 510(k) number is K200104.

When did Oxylight receive FDA 510(k) clearance?

Oxylight received FDA 510(k) clearance on 2020-06-04, under 510(k) number K200104.

Who is the listed applicant for Oxylight?

The FDA 510(k) record lists Raja Trading Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxylight?

The FDA product code for Oxylight is GEX. This falls under the Gastroenterology category.

Other records listing Raja Trading Company, Inc. 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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