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) (10)

Premarket Exempt

Clear

Nihon Kohden Life Scope G7 Bedside Monitoring System - 04931921004593 Catalog Number : JA-170P

Device Description : Data acquisition unit (for CU-171R, CU-172R)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004609 Catalog Number : YS-118P0

Device Description : DAU connection cable, 0.9m

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004616 Catalog Number : YS-118P1

Device Description : DAU connection cable, 2.8m

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004623 Catalog Number : YS-118P2

Device Description : DAU connection cable, 5m

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004630 Catalog Number : YS-118P3

Device Description : DAU connection cable, 10m

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Nihon Kohden Life Scope G7 Bedside Monitoring System - 04931921004661 Catalog Number : WS-171P

Device Description : Recorder module (for CU-171R, CU-172R)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004678 Catalog Number : YS-118P8

Device Description : Recorder cable, 1.5m

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004685 Catalog Number : YS-118P9

Device Description : Recorder cable, 0.35m

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Nihon Kohden Life Scope G7 Bedside Monitoring System - 04931921004692 Catalog Number : QI-171P

Device Description : Rear option board (for CU-171R, CU-172R)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Nihon Kohden Life Scope G7 Bedside Monitoring System - 04931921004708 Catalog Number : QM-151P

Device Description : SD card (for CU-171R, CU-172R)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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