Cleared Traditional

K944654 - OXYGEN CONCENTRATION INDICATOR (FDA 510(k) Clearance)

K944654 · Aequitron Medical, Inc. · Anesthesiology device

Nov 1994

Decision

48d

Days

Class 2

Risk

K944654 is an FDA 510(k) clearance for the OXYGEN CONCENTRATION INDICATOR. This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 8, 1994, 48 days after receiving the submission on September 21, 1994.

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

Submission Details

510(k) Number	K944654 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 21, 1994
Decision Date	November 08, 1994
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement