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 2 results

510(k) Data Aggregation

K Number

Device Name

POCKET RESCUE

Manufacturer

CHEEN HOUNG ENT. CO. LTD.

Date Cleared

1997-09-26

(213 days)

Product Code

KGB

Regulation Number

868.5570

Why did this record match?

Product Code :

KGB

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a nonbreathing adult.

Device Description

Exhaled Air Pulmonary Resuscitators

Ask a Question

K Number

Device Name

ULTIMATE SEAL

Manufacturer

HANS RUDOLPH, INC.

Date Cleared

1996-06-20

(143 days)

Product Code

KGB

Regulation Number

868.5570

Why did this record match?

Product Code :

KGB

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

Page 1 of 1