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FDA 510(k) Application Details - K222443
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K222443
Device Name
Spirometer, Diagnostic
Applicant
FeelLife Health Inc.
Room 1903, Building A, No.9 Furong Road, Tantou Community
Songgang Subdistrict, BaoÆan District
Shenzhen 518104 CN
Other 510(k) Applications for this Company
Contact
May Xiao
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/12/2022
Decision Date
08/09/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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