Cleared Special

K990293 - ALADDIN II MONITORING OXYGEN/AIR MONITOR
(FDA 510(k) Clearance)

K990293 · Hamilton Medical, Inc. · Anesthesiology

Mar 1999

Decision

46d

Days

Class 2

Risk

K990293 is an FDA 510(k) clearance for the ALADDIN II MONITORING OXYGEN/AIR MONITOR, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Hamilton Medical, Inc. (Snellville, US). The FDA issued a Cleared decision on March 16, 1999, 46 days after receiving the submission on January 29, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number	K990293 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 1999
Decision Date	March 16, 1999
Days to Decision	46 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Statement