Minrad Inc. Nasal Scavenging Circuit

FDA 510(k) K072255 · Minrad, Inc.

Substantially Equivalent

510(k) numberK072255

Submission

Device name
Minrad Inc. Nasal Scavenging Circuit
Applicant
Minrad, Inc.
Orchard Park, NY, US
Received
August 13, 2007
Decision date
October 18, 2007
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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Questions and answers

When was Minrad Inc. Nasal Scavenging Circuit cleared by the FDA?

Minrad Inc. Nasal Scavenging Circuit (K072255) received a 510(k) decision of Substantially Equivalent on October 18, 2007, 66 days after the submission was received.

What is the product code of K072255?

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