RESUSCITATION TIMER, MODEL L770-CPR

K062080 · Allied Healthcare Products, Inc. · BTM · Oct 18, 2006 · Anesthesiology

Device Facts

• Record ID: K062080
• Device Name: RESUSCITATION TIMER, MODEL L770-CPR
• Applicant: Allied Healthcare Products, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2

Intended Use

The L770-CPR Resuscitation Timer gives an audible and visual guide to the proper inspiratory time and (BPM) breaths per minute during emergency manual ventilation. It displays the actual inspiratory time, (BPM) breaths per minute, and peak airway pressure.

Device Story

L770-CPR Resuscitation Timer provides audible/visual guidance for manual ventilation; monitors inspiratory time, breaths per minute (BPM), and peak airway pressure. Used in emergency settings by healthcare providers to assist in maintaining proper ventilation parameters. Device provides real-time feedback to clinician, facilitating adherence to ventilation protocols; potentially improves patient outcomes by ensuring consistent delivery of breaths during resuscitation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic resuscitation timer; provides audible and visual feedback; monitors inspiratory time, BPM, and peak airway pressure. Class II device (21 CFR 868.5915).

Indications for Use

Indicated for use as an audible and visual guide for inspiratory time and breaths per minute during emergency manual ventilation for patients requiring respiratory support.

Regulatory Classification

Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Submission Summary (Full Text)

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## Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2006

Mr. Wayne Karcher Regulatory Affairs Coordinator . Allied Healthcare Products, Incorporated Life Support Products 1720 Sublette Avenue Saint Louis, Missouri 63110

Re: K062080

Trade/Device Name: Resuscitation Timer, Model L770-CPR Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: July 19, 2006 Received: July 21, 2006

Dear Mr. Karcher:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Karcher

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510{k} Number: K062080

Device Name: L770-CPR Resuscitation Timer

Indications For Use:

The L770-CPR Resuscitation Timer gives an audible and visual guide to the proper inspiratory time and (BPM) breaths per minute during emergency manual ventilation. It displays the actual inspiratory time, (BPM) breaths per minute, and peak airway pressure.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

luy Saloom

ion of Anesthesiology, General Hospital,
ution Control, Dental Devices

Sumber