Cleared Traditional

MICROLAB SPIROMETER

K031102 · Micro Direct, Inc. · Anesthesiology
Dec 2003
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K031102 is an FDA 510(k) clearance for the MICROLAB SPIROMETER, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Micro Direct, Inc. (Lewiston, US). The FDA issued a Cleared decision on December 1, 2003, 238 days after receiving the submission on April 7, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K031102 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2003
Decision Date December 01, 2003
Days to Decision 238 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840