DATRIX LLC

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

No

Clear

Sirona - 00851074007002 Catalog Number :

Device Description : ECG Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

VX3+ - 00851074007019 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

VX3+ - 00851074007026 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00851074007033 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

CardioHolter - 00851074007040 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

VX3+ - 00851074007057 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

VX3+ - 00851074007064 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Sirona - 00851074007088 Catalog Number :

Device Description : Generic Sirona Kit

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

VX3+ - 00851074007095 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Sirona - 00851074007101 Catalog Number :

Device Description : Smart Dock

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

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