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Found 2 results

510(k) Data Aggregation

K Number

Device Name

OMNI COLD GEL PACKS

Manufacturer

OMNI THERM, INC.

Date Cleared

1996-09-04

(163 days)

Product Code

Regulation Number

Type

Panel

Physical Medicine

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

OMNI COLD GEL PACKS

Manufacturer

OMNI THERM, INC.

Date Cleared

1996-02-13

(112 days)

Product Code

Regulation Number

Type

Panel

Physical Medicine

Reference & Predicate Devices

N/A

Predicate For

N/A

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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