Curasite
K-Number: K161991 · 2017-03-03
ApplicantIzun Pharmaceuticals
Decision Date2017-03-03
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Curasite is a medical device manufactured by Izun Pharmaceuticals. It received FDA 510(k) clearance on 2017-03-03 under approval number K161991. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Curasite?
Curasite is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Izun Pharmaceuticals. The 510(k) number is K161991.
When was Curasite approved by the FDA?
Curasite received FDA 510(k) clearance on 2017-03-03, under approval number K161991.
What company makes Curasite?
Curasite is manufactured by Izun Pharmaceuticals.
What is the FDA product code for Curasite?
The FDA product code for Curasite is FRO. This falls under the Anesthesiology 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.