Titan Ag 200
K-Number: K173844 · 2018-08-09
ApplicantSpecialty Fibres and Materials, Ltd.
Decision Date2018-08-09
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Titan Ag 200 is a medical device manufactured by Specialty Fibres and Materials, Ltd.. It received FDA 510(k) clearance on 2018-08-09 under approval number K173844. 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 Titan Ag 200?
Titan Ag 200 is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Specialty Fibres and Materials, Ltd.. The 510(k) number is K173844.
When was Titan Ag 200 approved by the FDA?
Titan Ag 200 received FDA 510(k) clearance on 2018-08-09, under approval number K173844.
What company makes Titan Ag 200?
Titan Ag 200 is manufactured by Specialty Fibres and Materials, Ltd..
What is the FDA product code for Titan Ag 200?
The FDA product code for Titan Ag 200 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.