Hydrofera Blue READY - Border
K-Number: K190268 · 2019-11-06
Device Summary
Hydrofera Blue READY - Border is a medical device manufactured by Hydrofera, LLC. It received FDA 510(k) clearance on 2019-11-06 under approval number K190268. 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 Hydrofera Blue READY - Border?
Hydrofera Blue READY - Border is a medical device that received FDA 510(k) clearance on 2019-11-06. It is manufactured by Hydrofera, LLC. The 510(k) number is K190268.
When was Hydrofera Blue READY - Border approved by the FDA?
Hydrofera Blue READY - Border received FDA 510(k) clearance on 2019-11-06, under approval number K190268.
What company makes Hydrofera Blue READY - Border?
Hydrofera Blue READY - Border is manufactured by Hydrofera, LLC.
What is the FDA product code for Hydrofera Blue READY - Border?
The FDA product code for Hydrofera Blue READY - Border 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.