Cleared Traditional

K953269 - SAFECIRCUIT MANIFOLD/PULMONARY UNIT (FDA 510(k) Clearance)

K953269 · Advanced Warming Systems, Inc. · Anesthesiology device

Dec 1996

Decision

526d

Days

Class 2

Risk

K953269 is an FDA 510(k) clearance for the SAFECIRCUIT MANIFOLD/PULMONARY UNIT. This device is classified as a Apparatus, Gas-scavenging (Class II - Special Controls, product code CBN).

Submitted by Advanced Warming Systems, Inc. (Lubbock, US). The FDA issued a Cleared decision on December 20, 1996, 526 days after receiving the submission on July 13, 1995.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number	K953269 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 1995
Decision Date	December 20, 1996
Days to Decision	526 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF