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

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (4) Gas-machine, anesthesia (BSZ) (3) DETECTOR AND ALARM, ARRHYTHMIA (DSI) (2) SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS (MSX) (1) VENTILATOR, CONTINUOUS, FACILITY USE (CBK) (1)

Premarket Exempt

No Yes

Clear

Spacelabs Healthcare - 10841522100413 Catalog Number : 12200903

Device Description : ABSORBER, NO BYPASS, 1KG (RE-ROUTE)

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Spacelabs Healthcare - 10841522100420 Catalog Number : 12200904

Device Description : ABSORBER, BYPASS, 2KG (RE-ROUTE) MRI

Device Class : 2

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : BSZ

Prescription Use : No

Device Count : 1

Spacelabs Healthcare - 10841522100437 Catalog Number : 12200905

Device Description : ABSORBER, BYPASS, 1KG (RE-ROUTE) MRI

Device Class : 2

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : BSZ

Prescription Use : No

Device Count : 1

Spacelabs Healthcare - 10841522100444 Catalog Number : 12200906

Device Description : ABSORBER, NO BYPASS, 2KG (RE-ROUTE) MRI

Device Class : 2

Duns Number: 145581588

Premarket Exempt : Yes

Product Code : BSZ

Prescription Use : No

Device Count : 1

Xhibit - 10841522100536 Catalog Number : 011-0241-01

Device Description : DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MSX, MHX

Prescription Use : Yes

Device Count : 1

qube - 10841522100550 Catalog Number : 91390

Device Description : COMPACT MONITOR,91390

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

qube - 10841522100574 Catalog Number : R-91390

Device Description : COMPACT MONITOR, 91390, REFURBISHED

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Trulink - 10841522100581 Catalog Number :

Device Description : 90600/90700,3-LEAD,DIN,PKGD CABLE

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Trulink - 10841522100598 Catalog Number : 012-0123-01

Device Description : CABLE,ECG,DIN,5-LEAD,305CM/10FT,IEC

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

Trulink - 10841522100611 Catalog Number : 012-0283-00

Device Description : LDWR,SET,DIN,SNAP,3-LEAD,46CM/18IN,AAMI,1/ST

Device Class : 2

Duns Number: 145581588

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

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