Suprasorb A + Ag R
K-Number: K183208 · 2019-08-15
Decision Date2019-08-15
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Suprasorb A + Ag R is a medical device manufactured by Speciality Fibres and Materials, Ltd.. It received FDA 510(k) clearance on 2019-08-15 under approval number K183208. 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 Suprasorb A + Ag R?
Suprasorb A + Ag R is a medical device that received FDA 510(k) clearance on 2019-08-15. It is manufactured by Speciality Fibres and Materials, Ltd.. The 510(k) number is K183208.
When was Suprasorb A + Ag R approved by the FDA?
Suprasorb A + Ag R received FDA 510(k) clearance on 2019-08-15, under approval number K183208.
What company makes Suprasorb A + Ag R?
Suprasorb A + Ag R is manufactured by Speciality Fibres and Materials, Ltd..
What is the FDA product code for Suprasorb A + Ag R?
The FDA product code for Suprasorb A + Ag R 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.