EasyOne Pro Respiratory Analysis System

FDA 510(k) K161534 · Ndd Medizintechnik AG

Substantially Equivalent

510(k) numberK161534

Submission

Device name
EasyOne Pro Respiratory Analysis System
Applicant
Ndd Medizintechnik AG
Zurich, CH
Received
June 3, 2016
Decision date
February 22, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTY – Calculator, Predicted Values, Pulmonary Function
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1890
Specialty
Anesthesiology

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Questions and answers

When was EasyOne Pro Respiratory Analysis System cleared by the FDA?

EasyOne Pro Respiratory Analysis System (K161534) received a 510(k) decision of Substantially Equivalent on February 22, 2017, 264 days after the submission was received.

What is the product code of K161534?

The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.