Cleared Traditional

EasyOne Pro Respiratory Analysis System

K161534 · Ndd Medizintechnik AG · Anesthesiology

Feb 2017

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K161534 is an FDA 510(k) clearance for the EasyOne Pro Respiratory Analysis System, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Ndd Medizintechnik AG (Zurich, CH). The FDA issued a Cleared decision on February 22, 2017, 264 days after receiving the submission on June 3, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number	K161534 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2016
Decision Date	February 22, 2017
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF