FDA 510(k) Application Details - K211585

Device Classification Name	Plethysmograph, Impedance   More FDA Info for this Device
510(K) Number	K211585
Device Name	Plethysmograph, Impedance
Applicant	Bodyport Inc. 970 Folsom Street San Francisco, CA 94107 US Other 510(k) Applications for this Company
Contact	Mara Korsunsky Other 510(k) Applications for this Contact
Regulation Number	870.2770   More FDA Info for this Regulation Number
Classification Product Code	DSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2021
Decision Date	07/29/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review