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510(k) K213754

SpiroHome Personal, SpiroHome Clinic by Inofab Saglik Teknolojileri A.S — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2023
Date Received
November 30, 2021
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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