FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 9 results

510(k) Data Aggregation

K Number

Device Name

QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1997-03-06

(31 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

Ask a Question

Ask a specific question about this device

K Number

Device Name

NOAH MONITORING ELECTRODE SYSTEM

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1997-03-04

(49 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

Ask a Question

Ask a specific question about this device

K Number

Device Name

DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1996-07-02

(160 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

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

K Number

Device Name

TEMPERATURE PROBE-TP150

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1996-04-04

(290 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

Ask a Question

Ask a specific question about this device

K Number

Device Name

TEMPERATURE PROBE-TP350

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1996-04-04

(290 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

Ask a Question

Ask a specific question about this device

K Number

Device Name

TEMPERATURE PROBE-TP450

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1996-04-04

(290 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

Ask a Question

Ask a specific question about this device

K Number

Device Name

TEMPERATURE PROBE-TP650

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1996-04-04

(290 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

Ask a Question

Ask a specific question about this device

K Number

Device Name

TEMPERATURE PROBE-TP250

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1996-04-04

(290 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

Ask a Question

Ask a specific question about this device

K Number

Device Name

TEMPERATURE PROBE-TP550

Manufacturer

CONTOUR MEDICAL TECHNOLOGY, INC.

Date Cleared

1996-04-04

(290 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

Ask a Question

Ask a specific question about this device

Page 1 of 1