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) (10)

Premarket Exempt

Clear

NA - 00841983100420 Catalog Number : IF-925P

Device Description : Communication Cable for Connecting a Masimo Pulse Oximeter

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100437 Catalog Number : IF-927P

Device Description : Communication cable for CareFusion ventilator

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100444 Catalog Number : IF-928P

Device Description : Communication Cable for Connecting a Dräger Medical Babylog® 8000 Plus Ventilator,

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100451 Catalog Number : IF-930P

Device Description : Communication cable for GE Healthcare anesthesia delivery system

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100468 Catalog Number : IF-932P

Device Description : Communication Cable for Connecting a MAQUET FLOW-i Anesthesia System

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100475 Catalog Number : IF-935P

Device Description : Communication cable for GE Healthcare ventilator

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100482 Catalog Number : IF-937P

Device Description : Communication Cable for Connecting a Somanetics INVOS 5100C

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100499 Catalog Number : IF-939P

Device Description : Communication cable for GE Healthcare Centiva/5 Critical Care ventilator

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100505 Catalog Number : IF-942P

Device Description : Communication cable for Dräger Medical Evita Infinity® V500 ventilator

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100512 Catalog Number : IF-943P

Device Description : Communication cable for Dräger Medical Babylog® VN500 ventilator

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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