Cleared Traditional

K924679 - OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
(FDA 510(k) Clearance)

K924679 · Air-Shields Vickers, Inc. · Anesthesiology

Feb 1995

Decision

888d

Days

Class 2

Risk

K924679 is an FDA 510(k) clearance for the OXYCARE(TM) OXYGEN CONTROLLER/MONITOR. This device is classified as a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (Class II — Special Controls, product code KLK).

Submitted by Air-Shields Vickers, Inc. (Hatboro, US). The FDA issued a Cleared decision on February 21, 1995, 888 days after receiving the submission on September 16, 1992.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2500.

Submission Details

510(k) Number	K924679 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1992
Decision Date	February 21, 1995
Days to Decision	888 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

Device Classification

Product Code	KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.2500