NIHON KOHDEN AMERICA, INC.

NIHON KOHDEN AMERICA, INC.

Address:15353 Barranca Pkwy,Irvine,CA,92618,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) (8) Amplitude-integrated electroencephalograph (OMA) (1) Full-montage Standard Electroencephalograph (GWQ) (1) Non-normalizing quantitative electroencephalograph software (OLT) (1) Standard polysomnograph with electroencephalograph (OLV) (1)

Premarket Exempt

No

Clear

NA - 00841983100000 Catalog Number : AA-674P

Device Description : SMART EXPANSION UNIT, 4 MP

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100017 Catalog Number : AE-918P

Device Description : Neuro unit, 8 channel

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : OMA

Prescription Use : Yes

Device Count : 1

NA - 00841983100024 Catalog Number : AY-631P-QM

Device Description : Input unit, 1 MULTI connector, Masimo SpO2

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100031 Catalog Number : AY-633P-QM

Device Description : Input unit, 3 MULTI connector, Masimo SpO2

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100048 Catalog Number : AY-651P-QM

Device Description : Input unit, 1 MULTI connector, Nellcor SpO2

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100055 Catalog Number : AY-653P-QM

Device Description : Input unit, 3 MULTI connector, Nellcor SpO2

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100062 Catalog Number : AY-671P-QM

Device Description : Input Unit, 1 MULTI connector NK SpO2

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100079 Catalog Number : AY-673P-QM

Device Description : Input Unit, 3 MULTI connector NK SpO2

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100109 Catalog Number : BC-112B

Device Description : ECG electrode lead, 2 pcs/set

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : OLT, GWQ, OLV

Prescription Use : Yes

Device Count : 1

NA - 00841983100116 Catalog Number : BJ-900PA

Device Description : ECG patient cable, 10 electrodes (AHA)

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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