Cleared Traditional

EasyOne Air Spirometer

K161536 · Ndd Medizintechnik AG · Anesthesiology
Jan 2017
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K161536 is an FDA 510(k) clearance for the EasyOne Air Spirometer, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Ndd Medizintechnik AG (Zurich, CH). The FDA issued a Cleared decision on January 5, 2017, 216 days after receiving the submission on June 3, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K161536 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2016
Decision Date January 05, 2017
Days to Decision 216 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