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FDA 510(k)

Opera Evo

K-Number: K202041 · 2020-10-15

ApplicantQuanta System Spa
Decision Date2020-10-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Opera Evo 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 2020-10-15 under 510(k) number K202041. 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 Opera Evo?

Opera Evo is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is Quanta System Spa. The 510(k) number is K202041.

When did Opera Evo receive FDA 510(k) clearance?

Opera Evo received FDA 510(k) clearance on 2020-10-15, under 510(k) number K202041.

Who is the listed applicant for Opera Evo?

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 Opera Evo?

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

Other records listing Quanta System Spa 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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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

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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