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) Electrocardiograph,Ambulatory(Without Analysis) (MWJ) (2) Oximeter (DQA) (2) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (2) Recorder, Magnetic Tape, Medical (DSH) (1)

Premarket Exempt

Clear

Q-Stress Patient Cable - 00812345022834 Catalog Number :

Device Description : Cable cleared with Q-Stress Stress Exercise System

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Q-Stress Patient Cable - 00812345022858 Catalog Number :

Device Description : Cable cleared with Q-Stress Stress Exercise System

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable - 00812345022957 Catalog Number :

Device Description : Patient cable cleared with Atria electrocargiograph

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

X12+ Patient Cable - 00812345023008 Catalog Number :

Device Description : Patient cable cleared with X12+

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DQA, DRG

Prescription Use : Yes

Device Count : 1

X12+ Patient Cable - 00812345023015 Catalog Number :

Device Description : Patient cable cleared with X12+

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DQA, DRG

Prescription Use : Yes

Device Count : 1

Q-Stress Patient Cable - 00812345023022 Catalog Number :

Device Description : Cable cleared with Q-Stress Stress Exercise System

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Q-Stress Patient Cable - 00812345023046 Catalog Number :

Device Description : Cable cleared with Q-Stress Stress Exercise System

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

H12+ Patient Cable - 00812345023060 Catalog Number :

Device Description : Patient cable cleared with H12+ recorder

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

H3+ Patient Cable - 00812345023077 Catalog Number :

Device Description : Patient cable cleared with H3+ recorder

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

H3+ Patient Cable - 00812345023084 Catalog Number :

Device Description : Patient cable cleared with H3+ recorder

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

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