FDA 510(k) Application Details - K200567

Device Classification Name	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic   More FDA Info for this Device
510(K) Number	K200567
Device Name	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant	Arterial Stiffness Inc. 1000 Westgate Drive Suite 101B Saint Paul, MN 55114 US Other 510(k) Applications for this Company
Contact	Jospeh Henry Shaw Other 510(k) Applications for this Contact
Regulation Number	870.2780   More FDA Info for this Regulation Number
Classification Product Code	JOM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2020
Decision Date	02/26/2021
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	N
Expedited Review