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