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

Medical device data system (OUG) (7) DETECTOR AND ALARM, ARRHYTHMIA (DSI) (1) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (1) RECORDER, PAPER CHART (DSF) (1)

Premarket Exempt

No Yes

Clear

Intesys Clinical Suite - 10841522100123 Catalog Number : V5.2.3

Device Description : HL7,ADT INTERFACE,92842

Device Class : 1

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

Intesys Clinical Suite - 10841522100130 Catalog Number : V5.2.3

Device Description : HL7 VITAL SIGNS INTERFACE,92843

Device Class : 1

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

Intesys Clinical Suite - 10841522100147 Catalog Number : V5.2.3

Device Description : ENTERPRISE NETWORK INTERFACE,92848

Device Class : 1

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

Intesys Clinical Suite - 10841522100154 Catalog Number : V5.2.3

Device Description : CUSTOM TRENDS,92876

Device Class : 1

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

Intesys Clinical Suite - 10841522100161 Catalog Number : V5.2.3

Device Description : 12 LEAD ECG INTERFACE,92877

Device Class : 1

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

Intesys Clinical Suite - 10841522100178 Catalog Number : V5.2.3

Device Description : VITAL SIGNS VIEWER,92880

Device Class : 1

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

Intesys Clinical Suite - 10841522100185 Catalog Number : V5.2.3

Device Description : PRINT MANAGER,92881

Device Class : 1

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : DSF

Prescription Use : Yes

Device Count : 1

Xprezznet - 10841522100192 Catalog Number : 1.3.1

Device Description : Spacelabs Network Interface

Device Class : 1

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Spacelabs Healthcare - 10841522100208 Catalog Number : 90499

Device Description : MODULE HOUSING,TWO BAY

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

UltraviewSL - 10841522100215 Catalog Number :

Device Description : MONITOR,BEDSIDE

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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