SPACELABS HEALTHCARE (WASHINGTON), INC

SPACELABS HEALTHCARE (WASHINGTON), INC

Address:35301 SE Center St,Snoqualmie,WA,98065,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Gas-Machine, Anesthesia (BSZ) (5) Ventilator, Continuous, Facility Use (CBK) (5) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (3) COMPUTER, DIAGNOSTIC, PROGRAMMABLE (DQK) (1) Oximeter (DQA) (1)

Premarket Exempt

No Yes

Clear

Arkon - 10841522100017 Catalog Number : ARKON

Device Description : Arkon, Anesthesia Delivery Machine

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : BSZ, CBK

Prescription Use : No

Device Count : 1

BleaseSirius - 10841522100024 Catalog Number : N/A

Device Description : BLEASESIRIUS ANAESTHESIA SYSTEM

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : BSZ, CBK

Prescription Use : Yes

Device Count : 1

BleaseFocus - 10841522100031 Catalog Number : Focus

Device Description : Focus Anesthetic Machine

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : BSZ, CBK

Prescription Use : Yes

Device Count : 1

BleaseGenius - 10841522100048 Catalog Number : Genius

Device Description : Genius Anesthetic Machine

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : BSZ, CBK

Prescription Use : Yes

Device Count : 1

900 Series Ventilator - 10841522100055 Catalog Number : 700900VENT

Device Description : 700/900 VENTILATORS

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : BSZ, CBK

Prescription Use : Yes

Device Count : 1

Flexport - 10841522100062 Catalog Number : 90439

Device Description : FLEXPORT,PULSION PICCO,INTERFACE,90439

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Xprezzon - 10841522100079 Catalog Number : N/A

Device Description : Bedside Monitor

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

XPREZZON - 10841522100093 Catalog Number : R-91393

Device Description : STATIONARY MONITOR, 91393, REFURBISHED

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

XPREZZON - 10841522100109 Catalog Number : L-91393

Device Description : 91393 STATIONARY MONITOR, LOANER

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Intesys Clinical Suite - 10841522100116 Catalog Number : V5.2.3

Device Description : SMART DISCLOSURE,92810

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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