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FDA 510(k)

Thunder, Thunder VT, Thunder HR

K-Number: K171711 · 2017-07-07

ApplicantQuanta System Spa
Decision Date2017-07-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thunder, Thunder VT, Thunder HR 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 2017-07-07 under 510(k) number K171711. 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 Thunder, Thunder VT, Thunder HR?

Thunder, Thunder VT, Thunder HR is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Quanta System Spa. The 510(k) number is K171711.

When did Thunder, Thunder VT, Thunder HR receive FDA 510(k) clearance?

Thunder, Thunder VT, Thunder HR received FDA 510(k) clearance on 2017-07-07, under 510(k) number K171711.

Who is the listed applicant for Thunder, Thunder VT, Thunder HR?

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 Thunder, Thunder VT, Thunder HR?

The FDA product code for Thunder, Thunder VT, Thunder HR is GEX. This falls under the Gastroenterology category.

Other records listing Quanta System Spa as applicant

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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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