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FDA 510(k) Application Details - K221058
Device Classification Name
Spirometer, Therapeutic (Incentive)
More FDA Info for this Device
510(K) Number
K221058
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
Lung Trainers, LLC
8000 NW 7 ST, STE 202
Miami, FL 33126 US
Other 510(k) Applications for this Company
Contact
Frank Acosta
Other 510(k) Applications for this Contact
Regulation Number
868.5690
More FDA Info for this Regulation Number
Classification Product Code
BWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/11/2022
Decision Date
07/05/2023
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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