MEDICOMP, INC.

Address:600 Atlantis Rd,Melbourne,FL,32904,US

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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

Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (2) Electrocardiograph, Ambulatory, With Analysis Algorithm (MLO) (1) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (1)

Premarket Exempt

Clear

CardioPAL SAVI - 00862887000340 Catalog Number :

Device Description : CardioPAL SAVI is a small, patient worn device, prescribed by physicians for pat CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.

Device Class : 2

Duns Number: 057729253

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

Cardiac Monitor - 00862887000357 Catalog Number :

Device Description : Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.

Device Class : 2

Duns Number: 057729253

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

Decipher Holter Monitor - 00862887000364 Catalog Number :

Device Description : Decipher Holter Monitor is a small, patient worn device, prescribed by physician Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.

Device Class : 2

Duns Number: 057729253

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

TelePatch Cardiac Monitor - 00862887000371 Catalog Number :

Device Description : TelePatch CM PM700 is a small, auto triggered, or patient activated, device, pre TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.

Device Class : 2

Duns Number: 057729253

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

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