NIHON KOHDEN AMERICA, INC.

Address:15353 Barranca Pkwy,Irvine,CA,92618,US

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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) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (1) Electromyograph, diagnostic (IKN) (1) Full-montage Standard Electroencephalograph (GWQ) (1) Non-normalizing quantitative electroencephalograph software (OLT) (1) STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (1)

Premarket Exempt

Clear

Neuropack X1 - 00841983100222 Catalog Number : DC-230BA

Device Description : Main unit for MEB-2300A

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Neuropack S1 - 00841983100239 Catalog Number : DC-940BA

Device Description : Main unit for MEB-9400

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

NA - 00841983100246 Catalog Number : DH-110A

Device Description : HOLDER, PSG-1100

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

NA - 00841983100253 Catalog Number : DH-170P

Device Description : Adapter

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100260 Catalog Number : DH-220P

Device Description : Mount adapter for mounting bedside monitor on the GF-210R multigas unit or GF-22 Mount adapter for mounting bedside monitor on the GF-210R multigas unit or GF-220R multigas/flow unit

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100277 Catalog Number : DH-221P

Device Description : WALL MOUNT, GF-210RA

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

NA - 00841983100284 Catalog Number : DI-120A

Device Description : ADAPTER DUAL MOUNT, PHOTIC / INPUT

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : OLT

Prescription Use : Yes

Device Count : 1

NA - 00841983100291 Catalog Number : DM-190P

Device Description : BASE STAND, G9 Core Unit

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100307 Catalog Number : DM-191P

Device Description : BASE DESK, G9 Core Unit

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00841983100314 Catalog Number : DZ-170P

Device Description : HOOK, BSM-1700

Device Class : 2

Duns Number: 021063219

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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