Cleared Traditional

SPM-300

K130322 · Bionet Co., Ltd. · Anesthesiology
Nov 2013
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K130322 is an FDA 510(k) clearance for the SPM-300, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Bionet Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on November 15, 2013, 280 days after receiving the submission on February 8, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K130322 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2013
Decision Date November 15, 2013
Days to Decision 280 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