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) (6) Full-montage Standard Electroencephalograph (GWQ) (2) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1) Non-Normalizing Quantitative Electroencephalograph Software (OLT) (1) STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (1) Standard Polysomnograph With Electroencephalograph (OLV) (1) Stimulator, Electrical, Evoked Response (GWF) (1) TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY (DRG) (1) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (1) Full-Montage Standard Electroencephalograph (GWQ) (1) Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (DRT) (1)

Premarket Exempt

Clear

NK-HealthProtect Wireless Surge Solution - 00841983104336 Catalog Number : A-WSS-002-ZA

Device Description : Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patie Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : DRG, MHX

Prescription Use : Yes

Device Count : 1

BluPRO® - 04931921019696 Catalog Number : TL-220T-A1

Device Description : Multi-site probe Adults, child (3 kg or more)

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF, OLT, OLV, GWQ, MHX, DRG, DRT

Prescription Use : Yes

Device Count : 1

NA - 04931921107676 Catalog Number : WS-371P

Device Description : Recorder module for BSM-3500

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 04931921113752 Catalog Number : DH-350P

Device Description : Handle for BSM-3500

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 10841983101493 Catalog Number : YG-101T

Device Description : Airway adapter for TG-900P

Device Class :

Duns Number: 021063219

Premarket Exempt : No

Product Code : CCK, MHX

Prescription Use : Yes

Device Count : 50

NA - 10841983101509 Catalog Number : YG-111T

Device Description : Airway adapter for TG-920P

Device Class :

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX, CCK

Prescription Use : Yes

Device Count : 30

cap-ONE - 10841983101516 Catalog Number : YG-122T

Device Description : Nasal adapter for TG-920P (oxygen cannula adjustment)

Device Class :

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX, CCK, GWF

Prescription Use : Yes

Device Count : 30

NA - 10841983101523 Catalog Number : YG-211T

Device Description : Airway adapter for adult and child

Device Class :

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWQ, CCK, MHX

Prescription Use : Yes

Device Count : 30

NA - 10841983101530 Catalog Number : YG-213T

Device Description : Airway adapter for neonate and child, TG-970P

Device Class :

Duns Number: 021063219

Premarket Exempt : No

Product Code : CCK, MHX, GWQ

Prescription Use : Yes

Device Count : 30

NA - 10841983101547 Catalog Number : YG-214T

Device Description : Airway adapter for neonate and child

Device Class :

Duns Number: 021063219

Premarket Exempt : No

Product Code : CCK, MHX

Prescription Use : Yes

Device Count : 30

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