Cleared Traditional

STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM

K012387 · Stethographics, Inc. · Anesthesiology

Apr 2002

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K012387 is an FDA 510(k) clearance for the STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM, a Calculator, Pulmonary Function Interpretor (diagnostic) (Class II — Special Controls, product code BZM), submitted by Stethographics, Inc. (Houston, US). The FDA issued a Cleared decision on April 23, 2002, 270 days after receiving the submission on July 27, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number	K012387 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 2001
Decision Date	April 23, 2002
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF