NATUS NEUROLOGY INCORPORATED

Address:3150 Pleasant View Road,Middleton,WI,53562,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, Blood-Flow, Ultrasonic (HEP) (2) Monitor, Ultrasonic, Nonfetal (JAF) (2) Stimulator, Electrical, Evoked Response (GWF) (2) System, Monitoring, Perinatal (HGM) (2) Electrode, Needle (GXZ) (1) Reduced- Montage Standard Electroencephalograph (OMC) (1)

Premarket Exempt

No Yes

Clear

Olympic CFM - 00382830008068 Catalog Number : OBM00042

Device Description : Neonatal Hydrogel Sensors

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : OMC

Prescription Use : No

Device Count : 1

NATUS NEUROLOGY - 00382830017664 Catalog Number :

Device Description : Disposable Monopolar Needle, 25mmx27G (24) per PK

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

NATUS NEUROLOGY - 00382830019095 Catalog Number :

Device Description : SYNERGY N PORTABLE 5 CH W/EP

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830020824 Catalog Number :

Device Description : P32-STIM POD 1 (A-D)-10' (CR)

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

NATUS NEUROLOGY - 00382830027885 Catalog Number :

Device Description : VERSALAB APM TWIN

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

NATUS NEUROLOGY - 00382830027892 Catalog Number :

Device Description : VERSALAB APM SINGLE

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

NATUS NEUROLOGY - 00382830027908 Catalog Number :

Device Description : VERSALAB LE

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

NATUS NEUROLOGY - 00382830027915 Catalog Number :

Device Description : VERSALAB SE

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : JAF

Prescription Use : Yes

Device Count : 1

NATUS NEUROLOGY - 00382830028004 Catalog Number :

Device Description : POCKET DOP 3 MAIN (II)

Device Class : 2

Duns Number: 874257488

Premarket Exempt : No

Product Code : HEP

Prescription Use : Yes

Device Count : 1

NATUS NEUROLOGY - 00382830028011 Catalog Number :

Device Description : POCKET DOP II MAIN

Device Class : 2

Duns Number: 874257488

Premarket Exempt : Yes

Product Code : HEP

Prescription Use : Yes

Device Count : 1

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