Cleared Traditional

GALEMED PEAK FLOW METER, MODELS 3751/3752

K022124 · Galemed Corp. · Anesthesiology
Apr 2003
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K022124 is an FDA 510(k) clearance for the GALEMED PEAK FLOW METER, MODELS 3751/3752, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Galemed Corp. (Wu-Jia, I-Lan, TW). The FDA issued a Cleared decision on April 3, 2003, 276 days after receiving the submission on July 1, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number K022124 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2002
Decision Date April 03, 2003
Days to Decision 276 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZH — Meter, Peak Flow, Spirometry
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1860

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