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

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (5) TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY (DRG) (5) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (4) Electrode, Cutaneous (GXY) (1)

Premarket Exempt

Clear

cap-ONE - 14931921902537 Catalog Number :

Device Description : cap-ONE mask, adult

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 10

cap-ONE - 14931921902544 Catalog Number : YG-272TW

Device Description : cap-One mask, adult

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 10

cap-ONE - 14931921902551 Catalog Number :

Device Description : cap-ONE mask, adult, large

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 10

cap-ONE - 14931921902568 Catalog Number : YG-282TW

Device Description : cap-One mask, adult, large

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 10

AE-120A EEG Head Set - 14931921903053 Catalog Number : NE-090S1

Device Description : Disposable Electrode for EEG

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 6

NA - 14931921903473 Catalog Number : YP-840T

Device Description : Disposable cuff for infants

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX, DRG

Prescription Use : Yes

Device Count : 20

NA - 14931921903480 Catalog Number : YP-841T

Device Description : Disposable cuff for children

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : DRG, MHX

Prescription Use : Yes

Device Count : 20

NA - 14931921903497 Catalog Number : YP-842T

Device Description : Disposable cuff for adults, small

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : DRG, MHX

Prescription Use : Yes

Device Count : 20

NA - 14931921903503 Catalog Number : YP-843T

Device Description : Disposable cuff for adults, standard

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : DRG, MHX

Prescription Use : Yes

Device Count : 20

NA - 14931921903510 Catalog Number : YP-844T

Device Description : Disposable cuff for adults, large

Device Class :

Duns Number: 690568050

Premarket Exempt : No

Product Code : DRG, MHX

Prescription Use : Yes

Device Count : 20

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