BRAEMAR MANUFACTURING, LLC

Address:1285 Corporate Center Dr Ste 150,EAGAN,MN,55121,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

Detector And Alarm, Arrhythmia (DSI) (7) Electrocardiograph, Ambulatory, With Analysis Algorithm (MLO) (3)

Premarket Exempt

No Yes

Clear

Millennia Software - B146C4MA000 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

Millennia Software - B146C4MA020 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

Millennia Software - B146C4MA080 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

C5 Monitor - B146C5M0 Catalog Number :

Device Description : Ambulatory ECG Monitoring system

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C5 Monitor NOBT - B146C5M20 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C5 Sensor - B146C5S0 Catalog Number :

Device Description : Ambulatory ECG Monitoring system

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C6 Sensor D - B146C6D0 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C6 Sensor - B146C6D10 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C6 Sensor 3.0 - B146C6E10 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

C6 Monitor UGW - B146C6M20 Catalog Number :

Device Class : 2

Duns Number: 049529118

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

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