REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

Address:ASCENT 1, FARNBOROUGH AEROSPACE CENTRE,FARNBOROUGH Hampshire,GB

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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) (8) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (2)

Premarket Exempt

Clear

Tempus Pro - 05060472440228 Catalog Number :

Device Description : Tempus Pro 5-Lead ECG Cable (AAMI) 8ft

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Tempus Pro - 05060472440235 Catalog Number :

Device Description : Tempus Pro 12-Lead ECG Cable (AAMI) 8ft

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Tempus Pro - 05060472440280 Catalog Number :

Device Description : Tempus Pro 3-Lead Neonatal ECG Cable (AAMI) 6ft

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Tempus Pro - 05060472440297 Catalog Number :

Device Description : Tempus Lithium-Ion Battery (Black)

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Tempus Pro - 05060472440303 Catalog Number :

Device Description : Mains Power Supply

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Tempus Pro - 05060472440310 Catalog Number :

Device Description : Battery Charger

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Tempus Pro - 05060472440389 Catalog Number :

Device Description : Tempus Pro Vehicle Adapter

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Tempus Pro - 05060472440419 Catalog Number :

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Tempus IC2 - 05060472440433 Catalog Number :

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Tempus IC2 - 05060472440440 Catalog Number :

Device Description : Consumables Replenishment Kit

Device Class : 2

Duns Number: 896707940

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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