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FDA 510(k)

Hydrofera Blue READY - Border

K-Number: K190268 · 2019-11-06

ApplicantHydrofera, LLC
Decision Date2019-11-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Hydrofera Blue READY - Border is the device name listed in this FDA 510(k) record. The listed applicant is Hydrofera, LLC. It received FDA 510(k) clearance on 2019-11-06 under 510(k) 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. The listed applicant is Hydrofera, LLC. The 510(k) number is K190268.

When did Hydrofera Blue READY - Border receive FDA 510(k) clearance?

Hydrofera Blue READY - Border received FDA 510(k) clearance on 2019-11-06, under 510(k) number K190268.

Who is the listed applicant for Hydrofera Blue READY - Border?

The FDA 510(k) record lists Hydrofera, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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