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FDA 510(k)

Empower H65

K-Number: K180423 · 2018-03-15

ApplicantQuanta System Spa
Decision Date2018-03-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Empower H65 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 2018-03-15 under 510(k) number K180423. 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 Empower H65?

Empower H65 is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is Quanta System Spa. The 510(k) number is K180423.

When did Empower H65 receive FDA 510(k) clearance?

Empower H65 received FDA 510(k) clearance on 2018-03-15, under 510(k) number K180423.

Who is the listed applicant for Empower H65?

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 Empower H65?

The FDA product code for Empower H65 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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