FDA 510(k) Application Details - K181894

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

  More FDA Info for this Device
510(K) Number K181894
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant RGB Medical Devices SA
Calle de Alfonso Gomez 42
Madrid 28037 ES
Other 510(k) Applications for this Company
Contact Ricardo Ruiz
Other 510(k) Applications for this Contact
Regulation Number 870.1130

  More FDA Info for this Regulation Number
Classification Product Code DXN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/16/2018
Decision Date 05/09/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact