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Found 2 results

510(k) Data Aggregation

K Number

Device Name

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)

Manufacturer

ARC MEDICAL, INC.

Date Cleared

2007-04-13

(182 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

K083702,K093426,K120079

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

Manufacturer

ARC MEDICAL, INC.

Date Cleared

2001-12-20

(244 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

K013089,K014281

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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