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) (4) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (4) Wire, Guide, Catheter (DQX) (2)

Premarket Exempt

Clear

Surveyor S12 - 00817655022703 Catalog Number :

Device Description : Patient Monitor

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Surveyor S19 - 00817655022710 Catalog Number :

Device Description : Patient Monitor

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Surveyor S19 - 00817655022727 Catalog Number :

Device Description : Patient Monitor

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Surveyor S19 - 00817655022734 Catalog Number :

Device Description : Patient Monitor

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

WAM - 00817655022741 Catalog Number :

Device Description : Wireless 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 250c - 00817655022758 Catalog Number :

Device Description : Electrocardiograph

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

CardioConfirm - 00817655022765 Catalog Number :

Device Description : Cardiology Data Software

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

CardioConfirm - 00817655022772 Catalog Number :

Device Description : Cardiology Data Software

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

ELI 280 - 00817655022789 Catalog Number :

Device Description : Electrocardiograph

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

ELI Edit - 00817655022796 Catalog Number :

Device Description : Cardiology Data Software

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

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