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) (4) STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (4) Full-montage Standard Electroencephalograph (GWQ) (1) MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) (MWI) (1)

Premarket Exempt

Clear

NA - 00841983100529 Catalog Number : IF-948P

Device Description : Communication cable for Edwards Lifesciences clinical platform EV1000

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100536 Catalog Number : JA-694PA

Device Description : Data acquisition unit

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100543 Catalog Number : JA-920P

Device Description : Interface Unit

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100550 Catalog Number : JB-101B

Device Description : Breakout Box

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

NA - 00841983100567 Catalog Number : JB-102B

Device Description : BREAKOUT BOX, 24INP, MEE-1000

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

NA - 00841983100574 Catalog Number : JB-110A

Device Description : Head Box

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

NA - 00841983100581 Catalog Number : JB-210B

Device Description : BREAKOUT BOX, MEE-2000

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

NA - 00841983100598 Catalog Number : JB-232B

Device Description : AMP UNIT, 32 CH., MEE-2000 - G1

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

NA - 00841983100604 Catalog Number : JC-103TA

Device Description : ECG connection cord

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

NA - 00841983100611 Catalog Number : JC-906PA

Device Description : ECG Electrode Cord (3/6 Electrodes) (AHA)

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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