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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN

Manufacturer

CUSTOM SERVICES INTL., INC.

Date Cleared

1997-01-22

(163 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN

Manufacturer

CUSTOM SERVICES INTL., INC.

Date Cleared

1997-01-22

(163 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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