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Found 4 results

510(k) Data Aggregation

K Number

K970603

Device Name

D SERIES ELECTRODE

Manufacturer

CMC SENSE-IT, INC.

Date Cleared

1997-04-01

(42 days)

Product Code

Regulation Number

Type

Panel

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

K963159

Device Name

CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES

Manufacturer

CMC SENSE-IT, INC.

Date Cleared

1996-12-11

(119 days)

Product Code

Regulation Number

Type

Panel

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

K955815

Device Name

G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE

Manufacturer

CMC SENSE-IT, INC.

Date Cleared

1996-07-23

(210 days)

Product Code

Regulation Number

Type

Panel

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

K955800

Device Name

SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE

Manufacturer

CMC SENSE-IT, INC.

Date Cleared

1996-05-17

(147 days)

Product Code

Regulation Number

Type

Panel

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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