Cleared Traditional

K922738 - VTI OXYGEN ANALYZER
(FDA 510(k) Clearance)

K922738 · Vascular Technology Incorporated · Anesthesiology device

Jan 1993

Decision

233d

Days

Class 2

Risk

K922738 is an FDA 510(k) clearance for the VTI OXYGEN ANALYZER. This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).

Submitted by Vascular Technology Incorporated (Chelmsford, US). The FDA issued a Cleared decision on January 27, 1993, 233 days after receiving the submission on June 8, 1992.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number	K922738 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 08, 1992
Decision Date	January 27, 1993
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement