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510(k) K222525

Alveoair Digital Spirometer by Roundworks Technologies Private Limited — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2023
Date Received
August 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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