FDA 510(k)

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K番号: K153756 · 2016-08-04

決定日2016-08-04

製品コードFRO

決定大幅同等

医療機器の概要

Microlyte Ag is the device name listed in this FDA 510(k) record. The listed applicant is Imbed Biosciences, Inc.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153756. 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.

よくある質問

What is the Microlyte Ag?

Microlyte Ag is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Imbed Biosciences, Inc.. The 510(k) number is K153756.

When did Microlyte Ag receive FDA 510(k) clearance?

Microlyte Ag received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153756.

Who is the listed applicant for Microlyte Ag?

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

What is the FDA product code for Microlyte Ag?

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

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医療機器の概要

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