FDA 510(k) Application Details - K213730

Device Classification Name	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic   More FDA Info for this Device
510(K) Number	K213730
Device Name	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant	Mesi, Development of Medical Devices, Ltd.; Mesi d.o.o. Leskoskova cesta 11A Ljubljana 1000 SI Other 510(k) Applications for this Company
Contact	Jakob Susteric 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	11/26/2021
Decision Date	04/21/2022
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	N
Expedited Review