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Found 2 results

510(k) Data Aggregation

K Number

Device Name

AMBULATORY (HOLTER) RECORDING SYSTEM

Manufacturer

BIOSENSOR CORP.

Date Cleared

1996-06-18

(487 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

AMBULATORY (HOLTER) RECORDING SYSTEM

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

AMBULATORY (HOLTER) RECORDING SYSTEM

Manufacturer

BIOSENSOR CORP.

Date Cleared

1996-02-09

(358 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

AMBULATORY (HOLTER) RECORDING SYSTEM

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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