Who is the manufacturer of RAD VALVE?

Khi, Inc. filed the 510(k) submission for RAD VALVE (K830404).

What is the FDA product code for RAD VALVE?

BTL. It is classified under 21 CFR 868.5925 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for RAD VALVE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RAD VALVE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RAD VALVE

K830404 · Khi, Inc. · BTL · Mar 17, 1983 · Anesthesiology

Device Facts

Record ID	K830404
Device Name	RAD VALVE
Applicant	Khi, Inc.
Product Code	BTL · Anesthesiology
Decision Date	Mar 17, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5925
Device Class	Class 2

Regulatory Classification

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

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RAD VALVE

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