IODOFLEX
K-Number: K190756 · 2019-12-20
ApplicantSmith & Nephew Medical, Ltd.
Decision Date2019-12-20
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
IODOFLEX is a medical device manufactured by Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2019-12-20 under approval number K190756. 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 IODOFLEX?
IODOFLEX is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Smith & Nephew Medical, Ltd.. The 510(k) number is K190756.
When was IODOFLEX approved by the FDA?
IODOFLEX received FDA 510(k) clearance on 2019-12-20, under approval number K190756.
What company makes IODOFLEX?
IODOFLEX is manufactured by Smith & Nephew Medical, Ltd..
What is the FDA product code for IODOFLEX?
The FDA product code for IODOFLEX 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.