EasyOne Sky Spirometer
K-Number: K230178 · 2023-10-19
ApplicantNdd Medizintechnik AG
Decision Date2023-10-19
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
EasyOne Sky Spirometer is a medical device manufactured by Ndd Medizintechnik AG. It received FDA 510(k) clearance on 2023-10-19 under approval number K230178. 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 Sky Spirometer?
EasyOne Sky Spirometer is a medical device that received FDA 510(k) clearance on 2023-10-19. It is manufactured by Ndd Medizintechnik AG. The 510(k) number is K230178.
When was EasyOne Sky Spirometer approved by the FDA?
EasyOne Sky Spirometer received FDA 510(k) clearance on 2023-10-19, under approval number K230178.
What company makes EasyOne Sky Spirometer?
EasyOne Sky Spirometer is manufactured by Ndd Medizintechnik AG.
What is the FDA product code for EasyOne Sky Spirometer?
The FDA product code for EasyOne Sky 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.