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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

Light, Surgical, Fiberoptic (FST) (5) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (4) Oximeter (DQA) (1)

Premarket Exempt

No Yes

Clear

Waveline EZ - 00815871021920 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Waveline Pro - 00815871021937 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Waveline Touch - 00815871021944 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Trax - 00815871021951 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Echo - 00815871021968 Catalog Number :

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871021982 Catalog Number :

Device Description : SINGLE MAXX LUXX LED

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871021999 Catalog Number :

Device Description : DUAL MAXX LUXX LED W/HD

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022002 Catalog Number :

Device Description : DUAL MAXX LUXX LED W/HD

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022019 Catalog Number :

Device Description : MAXX LUXX LED W/MON

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022026 Catalog Number :

Device Description : MAXX LUXX LED, VIDEO READY

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

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