MORTARA INSTRUMENT, INC.

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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 (DPS) (5) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (4) Cable, Transducer And Electrode, Patient, (Including Connector) (DSA) (1)

Premarket Exempt

Clear

AM12 - 00817655023137 Catalog Number :

Device Description : Wired Acquisition System cleared with the ELI 230 Electrocardiograph

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

ELI 150c - 00817655023144 Catalog Number :

Device Description : Electrocardiograph

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

ELI 250c - 00817655023168 Catalog Number :

Device Description : Electrocardiograph

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Surveyor S19 - 00817655023175 Catalog Number :

Device Description : Patient Monitor

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Q-Stress - 00817655023182 Catalog Number :

Device Description : Cardiac Stress Testing System

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

ELI 250c - 00817655023212 Catalog Number :

Device Description : Electrocardiograph

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Surveyor Central - 00817655023229 Catalog Number :

Device Description : Patient Monitoring Central Station

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Surveyor Central - 00817655023236 Catalog Number :

Device Description : Patient Monitoring Central Station

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Surveyor Central - 00817655023243 Catalog Number :

Device Description : Patient Monitoring Central Station

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Clear Choice Adapter - 10812345022176 Catalog Number :

Device Description : ECG Adapter

Device Class :

Duns Number: 062046149

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 10

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