NIHON KOHDEN CORPORATION

Address:486 Nanokaichi,Gunma Tokyo,JP

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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

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (9) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (4) Full-montage Standard Electroencephalograph (GWQ) (2) TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY (DRG) (1)

Premarket Exempt

Clear

NA - 14931921885694 Catalog Number : YG-211T

Device Description : Airway adapter for adult and child

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : GWQ, CCK, MHX

Prescription Use : Yes

Device Count : 30

cap-ONE - 14931921886202 Catalog Number : YG-232T

Device Description : Cap-ONE Mask, Pediatric

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 10

NA - 14931921889722 Catalog Number : YG-600P

Device Description : Water trap

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 12

NA - 14931921889739 Catalog Number : YG-610P

Device Description : Sampling line

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 25

NA - 14931921890025 Catalog Number : YG-213T

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

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK, MHX, GWQ

Prescription Use : Yes

Device Count : 30

cap-ONE - 14931921895709 Catalog Number : YG-242T

Device Description : Cap-ONE Mask, Infant

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 10

NA - 14931921898359 Catalog Number : TL-535U

Device Description : SpO2 Probe, Disposable, Neonates and Preterm Infants

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : DRG, MHX

Prescription Use : Yes

Device Count : 5

NA - 14931921899295 Catalog Number : YG-214T

Device Description : Airway adapter for neonate and child

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX, CCK

Prescription Use : Yes

Device Count : 30

cap-ONE - 14931921900359 Catalog Number : YG-225T

Device Description : EtCO2 Nasal / Oral Probe w/ pressure control, Adult

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 10

cap-ONE - 14931921900373 Catalog Number : YG-235T

Device Description : EtCO2 Nasal / Oral Probe w/ pressure control, pediatric

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 10

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