NIHON KOHDEN CORPORATION

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) (7) MEDIA, ELECTROCONDUCTIVE (GYB) (2) Stimulator, Nerve, Peripheral, Electric (KOI) (1)

Premarket Exempt

No

Clear

NA - 00841983103865 Catalog Number : DH-350P

Device Description : Handle for BSM-3500

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983103872 Catalog Number : WS-371P

Device Description : Recorder module for BSM-3500

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Elefix - 00841983104121 Catalog Number : A/ELEFIX-SAMPLE

Device Description : ELEFIX, 1 SAMPLE TUBE (CONDUCTIVE EEG PASTE)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : GYB

Prescription Use : Yes

Device Count : 1

skinPure - 00841983104138 Catalog Number : A/SKINPURE-SAMPLE

Device Description : SKINPURE, 1 SAMPLE TUBE (SKIN PREPARATION GEL)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : GYB

Prescription Use : Yes

Device Count : 1

Smart Cable NMT Module and Accessories - 04931921000045 Catalog Number : DH-101P

Device Description : Holder

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : KOI

Prescription Use : Yes

Device Count : 1

NA - 04931921000243 Catalog Number : JL-632P

Device Description : SpO2 connection cord (for Masimo SpO2 probe)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 04931921000540 Catalog Number : IF-954P

Device Description : Communication cable for connecting a mindray A3/A5/A7 anesthesia workstation

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 04931921000557 Catalog Number : IF-957P

Device Description : Communication cable for connecting a Cheetah Medical NICOM/ Starling SV hemodyna Communication cable for connecting a Cheetah Medical NICOM/ Starling SV hemodynamic monitor

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 04931921000649 Catalog Number : YS-113P8

Device Description : VL cable set, (second)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 04931921000656 Catalog Number : YS-113P9

Device Description : VL cable set, (second)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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