DATRIX LLC

Address:340 State Pl,Escondido,CA,92029,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

Electrocardiograph,Ambulatory(Without Analysis) (MWJ) (10)

Premarket Exempt

Clear

Performer + - 00851074007118 Catalog Number :

Device Description : ECG Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Sirona - 00851074007125 Catalog Number :

Device Description : Sirona B PC App

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Sirona - 00851074007132 Catalog Number :

Device Description : Sirona B iOS App

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Sirona - 00851074007149 Catalog Number :

Device Description : Sirona B Android App

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

VX3+ - 00851074007156 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

AMI - 00851074007163 Catalog Number :

Device Description : ECG Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Cardiostaff - 00851074007170 Catalog Number : RX22711-003

Device Description : Sirona Android App

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

CardioLabs - 00851074007187 Catalog Number :

Device Description : ECG Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Cardiostaff - 00851074007194 Catalog Number : RX22773-003

Device Description : Sirona PC App

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Broomwell - 00851074007200 Catalog Number : RX93030-004

Device Description : Cardiac Monitor / ECG Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

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