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FDA 510(k)

EasyOne Pro Respiratory Analysis System

K-Number: K161534 · 2017-02-22

ApplicantNdd Medizintechnik AG
Decision Date2017-02-22
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EasyOne Pro Respiratory Analysis System is a medical device manufactured by Ndd Medizintechnik AG. It received FDA 510(k) clearance on 2017-02-22 under approval number K161534. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasyOne Pro Respiratory Analysis System?

EasyOne Pro Respiratory Analysis System is a medical device that received FDA 510(k) clearance on 2017-02-22. It is manufactured by Ndd Medizintechnik AG. The 510(k) number is K161534.

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

EasyOne Pro Respiratory Analysis System received FDA 510(k) clearance on 2017-02-22, under approval number K161534.

What company makes EasyOne Pro Respiratory Analysis System?

EasyOne Pro Respiratory Analysis System is manufactured by Ndd Medizintechnik AG.

What is the FDA product code for EasyOne Pro Respiratory Analysis System?

The FDA product code for EasyOne Pro Respiratory Analysis System is BTY.

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Other Devices by Ndd Medizintechnik AG

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Official Source

View on FDA Database →

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