Cleared Traditional

VENTILAIR II MEDICAL AIR COMPRESSOR

K041781 · Hamilton Medical AG · Anesthesiology

Mar 2005

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K041781 is an FDA 510(k) clearance for the VENTILAIR II MEDICAL AIR COMPRESSOR, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Hamilton Medical AG (Reno, US). The FDA issued a Cleared decision on March 14, 2005, 256 days after receiving the submission on July 1, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number	K041781 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2004
Decision Date	March 14, 2005
Days to Decision	256 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF