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) (9) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (1)

Premarket Exempt

Clear

NA - 00841983100321 Catalog Number : GF-210RA

Device Description : Multi-Gas Module

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

NA - 00841983100338 Catalog Number : IF-912P

Device Description : Communication Cable for Connecting an External Device Which Outputs Analog Voltage Signal,

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100345 Catalog Number : IF-913P

Device Description : Communication Cable for Connecting Radiometer MicroGas 7650 Rapid Transcutaneous Monitor

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100352 Catalog Number : IF-914P

Device Description : Communication Cable for Connecting Radiometer TCM4, TCM40 or TCM Combi M Transcu Communication Cable for Connecting Radiometer TCM4, TCM40 or TCM Combi M Transcutaneous Monitor,

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100369 Catalog Number : IF-916P

Device Description : Communication Cable for Connecting Newport Medical Instruments Ventilator

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100376 Catalog Number : IF-917P

Device Description : Communication Cable for Connecting Hamilton Medical Ventilator,

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100383 Catalog Number : IF-919P

Device Description : Communication Cable for Connecting a Covidien-Nellcor OxiMaxTM N-600xTM Pulse Oximeter

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100390 Catalog Number : IF-920P

Device Description : Communication Cable for Connecting Drager Medical Anesthesia Workstation

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100406 Catalog Number : IF-922P

Device Description : Communication Cable for Connecting Hospira SO2/CCO Monitor

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100413 Catalog Number : IF-923P

Device Description : Communication Cable for Connecting Puritan Bennett Ventilator, 7200

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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