FDA 510(k) Application Details - DEN210022

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210022
Device Name	PMD-200
Applicant	Medasense Biometrics Ltd. 4 Hachilazon Street Ramat Gan 5252268 IL Other 510(k) Applications for this Company
Contact	Rachel Weissbrod Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2021
Decision Date	02/17/2023
Decision	DENG -
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review