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FDA 510(k)

Chrome

K-Number: K202503 · 2020-11-18

ApplicantQuanta System Spa
Decision Date2020-11-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Chrome is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K202503. 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 Chrome?

Chrome is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Quanta System Spa. The 510(k) number is K202503.

When did Chrome receive FDA 510(k) clearance?

Chrome received FDA 510(k) clearance on 2020-11-18, under 510(k) number K202503.

Who is the listed applicant for Chrome?

The FDA 510(k) record lists Quanta System Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chrome?

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

Other records listing Quanta System Spa as applicant

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Related Devices (Code: GEX)

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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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