Alveoair Digital Spirometer
K-Number: K222525 · 2023-08-28
Decision Date2023-08-28
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Alveoair Digital Spirometer is a medical device manufactured by Roundworks Technologies Private Limited. It received FDA 510(k) clearance on 2023-08-28 under approval number K222525. 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 Alveoair Digital Spirometer?
Alveoair Digital Spirometer is a medical device that received FDA 510(k) clearance on 2023-08-28. It is manufactured by Roundworks Technologies Private Limited. The 510(k) number is K222525.
When was Alveoair Digital Spirometer approved by the FDA?
Alveoair Digital Spirometer received FDA 510(k) clearance on 2023-08-28, under approval number K222525.
What company makes Alveoair Digital Spirometer?
Alveoair Digital Spirometer is manufactured by Roundworks Technologies Private Limited.
What is the FDA product code for Alveoair Digital Spirometer?
The FDA product code for Alveoair Digital 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.