Safecircuit Manifold/Pulmonary Unit

Q: What is the product code of K953269?

The FDA product code is CBN – Apparatus, Gas-Scavenging, a Class II (moderate risk) device regulated under 21 CFR 868.5430.

FDA 510(k) K953269 · Advanced Warming Systems, Inc.

Substantially Equivalent

510(k) numberK953269

Submission

Device name: Safecircuit Manifold/Pulmonary Unit
Applicant: Advanced Warming Systems, Inc.
Lubbock, TX, US
Received: July 13, 1995
Decision date: December 20, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: CBN – Apparatus, Gas-Scavenging
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5430
Specialty: Anesthesiology

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More from Minrad, Inc.

510(k)	Device	Decision
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Questions and answers

When was Safecircuit Manifold/Pulmonary Unit cleared by the FDA?

Safecircuit Manifold/Pulmonary Unit (K953269) received a 510(k) decision of Substantially Equivalent on December 20, 1996, 526 days after the submission was received.

What is the product code of K953269?

The FDA product code is CBN – Apparatus, Gas-Scavenging, a Class II (moderate risk) device regulated under 21 CFR 868.5430.