Cleared Traditional

MODEL 2800 PFT FILTER

K051712 · Air Safety, Ltd. · Anesthesiology

Sep 2005

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K051712 is an FDA 510(k) clearance for the MODEL 2800 PFT FILTER, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Air Safety, Ltd. (Mccordsville, US). The FDA issued a Cleared decision on September 1, 2005, 66 days after receiving the submission on June 27, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number	K051712 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2005
Decision Date	September 01, 2005
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF