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Found 2 results

510(k) Data Aggregation

K Number

Device Name

CARDIO TEAM II

Manufacturer

VISION ELECTRONICS

Date Cleared

1997-04-10

(255 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

VISION ELECTRONICS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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K Number

Device Name

CARDIACMONITOR

Manufacturer

VISION ELECTRONICS

Date Cleared

1997-02-28

(185 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

VISION ELECTRONICS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

The indications for use are the same.

Device Description

The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace. The recorded ECG is sent by an acoustic signal from an internal speaker, using standard telephone lines to a telephonic receiver. The CardiacMonitor is the size of a Credit-card by about 0.31" thick.

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