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) (5) MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) (DRT) (4) STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (4) TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY (DRG) (4) Electromyograph, diagnostic (IKN) (2) ELECTROCARDIOGRAPH (DPS) (1) MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) (MWI) (1)

Premarket Exempt

Clear

NA - 00841983100123 Catalog Number : BM-001B

Device Description : Extension Cable For NM-317Y3 NCS electrode, with 6 pin connector

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF, IKN

Prescription Use : Yes

Device Count : 1

NA - 00841983100130 Catalog Number : BM-230B

Device Description : Active electrode cable, for MEB-2300

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

NA - 00841983100147 Catalog Number : BM-701B

Device Description : Extension Cord For Headphones And Earphones BM-701B

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

NA - 00841983100154 Catalog Number : BR-903PA

Device Description : ECG Electrode Lead (3 Electrodes) AHA, clip type

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : DRG, MHX, DRT

Prescription Use : Yes

Device Count : 1

NA - 00841983100161 Catalog Number : BR-906PA

Device Description : ECG Electrode Lead (6 Electrodes) AHA, clip type

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX, DRG, DRT

Prescription Use : Yes

Device Count : 1

NA - 00841983100178 Catalog Number : BR-913PA

Device Description : Electrode lead, 3 electrodes (AHA) (Snap type),

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MWI, DRT, MHX, DRG

Prescription Use : Yes

Device Count : 1

NA - 00841983100185 Catalog Number : BR-916PA

Device Description : Electrode lead, 6 electrodes (AHA) (Snap type)

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : DRG, MHX, DRT

Prescription Use : Yes

Device Count : 1

NA - 00841983100192 Catalog Number : BR-923DA

Device Description : Electrode lead For For 15 lead AHA

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Life Scope G9 - 00841983100208 Catalog Number : CU-192RA

Device Description : CORE UNIT - G9 (core i7 1.5GHz)

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Neuromaster G1 - 00841983100215 Catalog Number : DC-200BA

Device Description : MAIN UNIT, MEE-2000, G1

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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