EasyOne Air Spirometer
K-Number: K161536 · 2017-01-05
ApplicantNdd Medizintechnik AG
Decision Date2017-01-05
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
EasyOne Air Spirometer is a medical device manufactured by Ndd Medizintechnik AG. It received FDA 510(k) clearance on 2017-01-05 under approval number K161536. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EasyOne Air Spirometer?
EasyOne Air Spirometer is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by Ndd Medizintechnik AG. The 510(k) number is K161536.
When was EasyOne Air Spirometer approved by the FDA?
EasyOne Air Spirometer received FDA 510(k) clearance on 2017-01-05, under approval number K161536.
What company makes EasyOne Air Spirometer?
EasyOne Air Spirometer is manufactured by Ndd Medizintechnik AG.
What is the FDA product code for EasyOne Air Spirometer?
The FDA product code for EasyOne Air Spirometer is BZG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.