Cleared Traditional

PERSONAL WHEEZOMETER

K090863 · Karmelsonix · Anesthesiology

Sep 2009

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K090863 is an FDA 510(k) clearance for the PERSONAL WHEEZOMETER, a Calculator, Pulmonary Function Interpretor (diagnostic) (Class II — Special Controls, product code BZM), submitted by Karmelsonix (Binyamina, IL). The FDA issued a Cleared decision on September 21, 2009, 175 days after receiving the submission on March 30, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number	K090863 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2009
Decision Date	September 21, 2009
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF