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Found 3 results

510(k) Data Aggregation

K Number

Device Name

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

Manufacturer

Date Cleared

1997-08-28

(178 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

ARISTO MEDICAL

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Device Description

ComSat Oximeter Sensors / ComSat Pulse Oximeter Probes

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA concerning the substantial equivalence of the ComSat Oximeter Sensors to a legally marketed predicate device. It does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

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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

Why did this record match?

Applicant Name (Manufacturer) :

ARISTO MEDICAL PRODUCTS, INC.

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

Why did this record match?

Applicant Name (Manufacturer) :

ARISTO MEDICAL PRODUCTS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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