NATUS MEDICAL INCORPORATED

Address:5955 Pacific Center Blvd,SAN DIEGO,CA,92121,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

Audiometer (EWO) (10) Stimulator, Auditory, Evoked Response (GWJ) (8)

Premarket Exempt

No Yes

Clear

Bio-logic - 00382830000826 Catalog Number : 203219

Device Description : OAE Preemie TreeTip

Device Class :

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 100

Bio-logic - 00382830000833 Catalog Number : 203333, 29423

Device Description : OAE 6mm Blue Ear Tip

Device Class :

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 20

Bio-logic - 00382830000840 Catalog Number : 203353, 29424

Device Description : OAE 6mm Blue Ear Tip

Device Class :

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 100

Natus - 00382830000871 Catalog Number : 101001

Device Description : Reusable Silver Disc Electrod silicone leads

Device Class :

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 10

Natus - 00382830000888 Catalog Number : 101004

Device Description : Resuable Silver-Chloride Disc Electrode silicon leads

Device Class :

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 10

Natus - 00382830000901 Catalog Number : 101001-T

Device Description : Reusable Silver Disc Electrode teflon lead

Device Class :

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 10

Natus - 00382830000918 Catalog Number : 101007-T

Device Description : Reusable Gold Disc electrode teflon leads

Device Class :

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 10

Bio-logic - 00382830000987 Catalog Number : 206202

Device Description : Halo Ear Muffins with Tab Electrodes

Device Class : 2

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Bio-logic - 00382830001007 Catalog Number : 202240

Device Description : Infant Tip Adapter for use with 580-SINSER Insert Earphones

Device Class : 2

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Bio-logic - 00382830001038 Catalog Number : 206920

Device Description : Halo EarMuffin Adapter Tube for use with 580-SINSER insert earphone

Device Class : 2

Duns Number: 962519208

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

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