MORTARA INSTRUMENT, INC.

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) Electrocardiograph,Ambulatory(Without Analysis) (MWJ) (4) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2)

Premarket Exempt

No

Clear

H12+ - 00812345021646 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+ - 00812345021653 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+ - 00812345021660 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

H3+ - 00812345021684 Catalog Number :

Device Description : Holter Recorder

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Ambulo 2400 - 00812345021714 Catalog Number :

Device Description : Ambulatory Non-invasive Blood Pressure System

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

Ambulo 2400 - 00812345021721 Catalog Number :

Device Description : Ambulatory Non-invasive Blood Pressure System

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

WAM - 00812345021745 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

WAM - 00812345021752 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

AM12 - 00812345021769 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

AM12 - 00812345021776 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

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