PURE CRYOGEN
K-Number: K153564 · 2016-03-29
Decision Date2016-03-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PURE CRYOGEN is a medical device manufactured by Air Liquide Healthcare America Corporation. It received FDA 510(k) clearance on 2016-03-29 under approval number K153564. 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 PURE CRYOGEN?
PURE CRYOGEN is a medical device that received FDA 510(k) clearance on 2016-03-29. It is manufactured by Air Liquide Healthcare America Corporation. The 510(k) number is K153564.
When was PURE CRYOGEN approved by the FDA?
PURE CRYOGEN received FDA 510(k) clearance on 2016-03-29, under approval number K153564.
What company makes PURE CRYOGEN?
PURE CRYOGEN is manufactured by Air Liquide Healthcare America Corporation.
What is the FDA product code for PURE CRYOGEN?
The FDA product code for PURE CRYOGEN 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.