Cleared Traditional

EasyOne Sky Spirometer

K230178 · Ndd Medizintechnik AG · Anesthesiology
Oct 2023
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K230178 is an FDA 510(k) clearance for the EasyOne Sky 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 October 19, 2023, 269 days after receiving the submission on January 23, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K230178 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2023
Decision Date October 19, 2023
Days to Decision 269 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