Empower H35
K-Number: K180426 · 2018-03-16
ApplicantQuanta System Spa
Decision Date2018-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Empower H35 is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2018-03-16 under approval number K180426. 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 H35?
Empower H35 is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by Quanta System Spa. The 510(k) number is K180426.
When was Empower H35 approved by the FDA?
Empower H35 received FDA 510(k) clearance on 2018-03-16, under approval number K180426.
What company makes Empower H35?
Empower H35 is manufactured by Quanta System Spa.
What is the FDA product code for Empower H35?
The FDA product code for Empower H35 is GEX. This falls under the Gastroenterology category.
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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.