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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
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