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Found 3 results

510(k) Data Aggregation

K Number

Device Name

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS

Manufacturer

Date Cleared

1997-01-07

(119 days)

Product Code

Regulation Number

Type

Panel

General Hospital

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

9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS

Manufacturer

Date Cleared

1996-11-26

(76 days)

Product Code

Regulation Number

Type

Panel

General Hospital

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

9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD

Manufacturer

Date Cleared

1996-11-26

(74 days)

Product Code

Regulation Number

Type

Panel

General Hospital

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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