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) Electrocardiograph,Ambulatory(Without Analysis) (MWJ) (2)

Premarket Exempt

Clear

ELI Edit - 00817655022802 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

Surveyor Central - 00817655022857 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

ELI 250c - 00817655022864 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 - 00817655022871 Catalog Number :

Device Description : Electrocardiograph

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

RScribe - 00817655022888 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 - 00817655022901 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 - 00817655022918 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

H12+ - 00817655022925 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

H12+ - 00817655022932 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Surveyor Central - 00817655022949 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

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