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Found 2 results

510(k) Data Aggregation

K Number

Device Name

ARISTO ESOPHAGEAL STETHOSCOPE

Manufacturer

ARISTO MEDICAL PRODUCTS, INC.

Date Cleared

1996-06-19

(93 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR

Manufacturer

ARISTO MEDICAL PRODUCTS, INC.

Date Cleared

1996-03-26

(68 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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