Cyber Ho
K-Number: K170331 · 2017-03-03
ApplicantQuanta System Spa
Decision Date2017-03-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Cyber Ho is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2017-03-03 under approval number K170331. 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 Cyber Ho?
Cyber Ho is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Quanta System Spa. The 510(k) number is K170331.
When was Cyber Ho approved by the FDA?
Cyber Ho received FDA 510(k) clearance on 2017-03-03, under approval number K170331.
What company makes Cyber Ho?
Cyber Ho is manufactured by Quanta System Spa.
What is the FDA product code for Cyber Ho?
The FDA product code for Cyber Ho 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.