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

N/A - 04931921004715 Catalog Number : DH-151P

Device Description : Adapter

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004722 Catalog Number : DH-152P

Device Description : Channel adapter

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004739 Catalog Number : DH-153P

Device Description : Recorder holder

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004746 Catalog Number : DH-154P

Device Description : IF holder

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004753 Catalog Number : DH-158P

Device Description : GF holder

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921004760 Catalog Number : DH-159P

Device Description : Unit holder

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 - 04931921004777 Catalog Number : KC-150P

Device Description : Cart (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 - 04931921004784 Catalog Number : DM-150P

Device Description : Stand (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 - 04931921004791 Catalog Number : KG-150P

Device Description : Wall mount kit (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 - 04931921004807 Catalog Number : YS-119P1

Device Description : HDMI cable, 10m

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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