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) (4) Electrocardiograph,Ambulatory(Without Analysis) (MWJ) (1)

Premarket Exempt

Clear

CardioDiagnostics - 00851074007354 Catalog Number : RX93030-006

Device Description : ECG Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Datrix - 00851074007361 Catalog Number : VX3+ Series T

Device Description : ECG Recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Zywie - 00851074007378 Catalog Number : RX93030-011

Device Description : ECG recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

CardioLabs - 00851074007385 Catalog Number : RX93030-012

Device Description : ECG Recorder (Event)

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

TLC Diagnostics - 00851074007392 Catalog Number : RX93030-013

Device Description : ECG recorder

Device Class : 2

Duns Number: 080555401

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

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