FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

I am sorry, but the provided text from the FDA document (K982215) is a letter regarding the substantial equivalence determination for a "Manual Resuscitator with ACE" device. It does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or any performance metrics for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document is a regulatory approval letter, not a scientific study report.

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K Number

K961867

Device Name

PEEP VALVE

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-08-13

(90 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K961329

Device Name

BAGRIGHT CHILD RESUSCITATOR

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-07-02

(85 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K961330

Device Name

BAGRIGHT INFANT RESUSCITATOR

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-07-02

(85 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K961369

Device Name

BAGRIGHT RESPOSABLE RESUSCITATOR

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-06-28

(80 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K961868

Device Name

RESPOSABLE CHILD RESUSCITATOR

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-06-28

(44 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K961882

Device Name

RESPOSABLE INFANT RESUSCITATOR

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-06-28

(44 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K961331

Device Name

BAGRIGHT RESPOSABLE CHILD RESUSCITATOR

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-06-28

(81 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K961332

Device Name

BAGRIGHT RESPOSABLE INFANT RESUSCITATOR

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-06-28

(81 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K953546

Device Name

MANUAL PULMONARY RESUSICITATOR

Manufacturer

MEDICAL MARKETING CONCEPTS

Date Cleared

1996-02-29

(216 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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