Alarm, Blood-Pressure

FDA product code DSJ · Class II (moderate risk) · 21 CFR 870.1100 · Cardiovascular

6510(k) clearances
0PMA approvals
4recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K190624EarlyVue VS30DSJ · Traditional Philips Medizin Systeme Boeblingen GmbH10/27/2019SE
K163649SureSigns VS3; SureSigns VS4DSJ · Special Philips Medical Systems03/31/2017SE
K151761SureSigns VS3, SureSigns VS4DSJ · Special Phillips Medical Systems09/29/2015SE
K133961Suresigns VS3, Suresigns VS4DSJ · Traditional Philips Medical Systems06/26/2014SE
K960916Sams 8000 Cardioplegia MonitorDSJ · Traditional 3M Health Care, Sarns06/04/1996SE
K910262Keller Vital Signs Monitor - KMS-890DSJ · Traditional Keller Medical Specialties Products, Inc.04/01/1991SE

Recalls

RecallProductFirmInitiated
Z-2655-2023 Class IIEarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2)…A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits… Philips North America Llc08/31/2023Open, Classified
Z-2654-2023 Class IIEarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and…A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits… Philips North America Llc08/31/2023Open, Classified
Z-1645-2023 Class IIEarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number:…EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an… Philips North America Llc03/06/2023Open, Classified
Z-1644-2023 Class IIEARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number:…EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an… Philips North America Llc03/06/2023Open, Classified