NKUS LAB

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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) TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY (DRG) (2)

Premarket Exempt

Clear

NA - 00851725007009 Catalog Number : RNS-9703-019

Device Description : Remote Network Station with 19” display

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00851725007016 Catalog Number : RNS-9703-024

Device Description : Remote Network Station with 24” display

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Prefense - 00851725007023 Catalog Number : EDNS-9001

Device Description : Prefense - Early Detection and Notification System (PC)

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX, DRG

Prescription Use : Yes

Device Count : 1

Prefense - 00851725007030 Catalog Number : EDNS-WS24

Device Description : Prefense 24" display

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : DRG, MHX

Prescription Use : Yes

Device Count : 1

NetKonnect - 00851725007047 Catalog Number : QP-983P

Device Description : NetKonnect

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NetKonnect - 00851725007054 Catalog Number : BS-981P

Device Description : NetKonnect Option BS-981P (15 Accounts)

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NetKonnect - 00851725007061 Catalog Number : BS-982P

Device Description : NetKonnect Option BS-982P (1000 Accounts)

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NetKonnect - 00851725007078 Catalog Number : BS-983P

Device Description : NetKonnect Option BS-983P (ReportKonnect Option)

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NetKonnect - 00851725007085 Catalog Number : BS-984P

Device Description : NetKonnect Option BS-984P (RNS Option)

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

NA - 00851725007092 Catalog Number : CGS-9001

Device Description : Communication Gateway Server CGS-9001 (Pager Commnunication Gateway Server)

Device Class : 2

Duns Number: 080352293

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

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