FDA 510(k)

BIAFINE

K-Number: K173549 · 2018-08-13

Decision Date2018-08-13

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

BIAFINE is a medical device manufactured by Valeant Pharmaceuticals. It received FDA 510(k) clearance on 2018-08-13 under approval number K173549. 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 BIAFINE?

BIAFINE is a medical device that received FDA 510(k) clearance on 2018-08-13. It is manufactured by Valeant Pharmaceuticals. The 510(k) number is K173549.

When was BIAFINE approved by the FDA?

BIAFINE received FDA 510(k) clearance on 2018-08-13, under approval number K173549.

What company makes BIAFINE?

BIAFINE is manufactured by Valeant Pharmaceuticals.

What is the FDA product code for BIAFINE?

The FDA product code for BIAFINE is FRO. This falls under the Anesthesiology category.

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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.