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) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (3)

Premarket Exempt

Clear

NA - 04931921000663 Catalog Number :

Device Description : Central Monitor Main Unit

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 04931921000694 Catalog Number :

Device Description : Transmitter

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 04931921001448 Catalog Number :

Device Description : Communication cable for connecting Medtronic PB-980

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Nihon Kohden Life Scope G5 Bedside Monitoring System - 04931921002018 Catalog Number : CU-151R

Device Description : Core unit

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Nihon Kohden Life Scope G5 Bedside Monitoring System - 04931921002056 Catalog Number : CU-152R

Device Description : Core Unit

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

N/A - 04931921002087 Catalog Number : AA-174P

Device Description : Multi amp unit

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Nihon Kohden Life Scope G5 Bedside Monitoring System - 04931921002094 Catalog Number : WS-151P

Device Description : Recorder module (for CU-151R, CU-152R)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Nihon Kohden Life Scope G5 Bedside Monitoring System - 04931921002100 Catalog Number : QI-151P

Device Description : Rear option board (for CU-151R, CU-152R)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 - 04931921002117 Catalog Number : QI-152P

Device Description : Side option board (for CU-152R, 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 G5 Bedside Monitoring System - 04931921002179 Catalog Number : QS-116P

Device Description : Software Kit (for CU-151R, CU-152R)

Device Class : 2

Duns Number: 690568050

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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