AMBU DISPOSABLE PRESSURE MANOMETER

K040991 · Ambu, Inc. · CAP · Jul 22, 2004 · Anesthesiology

Device Facts

• Record ID: K040991
• Device Name: AMBU DISPOSABLE PRESSURE MANOMETER
• Applicant: Ambu, Inc.
• Product Code: CAP · Anesthesiology
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2600
• Device Class: Class 2

Intended Use

Ambu Disposable Pressure Manometer will be used to provide visual indication of the patient's airway pressure and may be attached to the manometer port on manual resuscitators, hyperinflation bags, CPAP Mask or CPAP Circuits.

Device Story

Ambu Disposable Pressure Manometer is a single-use device designed to monitor airway pressure during manual ventilation or CPAP therapy. It connects directly to the manometer port of manual resuscitators, hyperinflation bags, or CPAP circuits. The device provides a real-time visual indication of pressure levels to the clinician, allowing for monitoring of airway pressure during patient ventilation. It is intended for use in clinical settings by healthcare professionals to assist in managing patient airway pressure and ensuring safe delivery of ventilation or CPAP support.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-use pressure manometer. Mechanical sensing principle for visual pressure indication. Designed for attachment to standard manometer ports on respiratory equipment.

Indications for Use

Indicated for use as a visual indicator of airway pressure in patients requiring manual resuscitation, hyperinflation, or CPAP therapy. No specific age or gender contraindications provided.

Regulatory Classification

Identification

An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Submission Summary (Full Text)

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JUL 22 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sanjay Parikh Technical & Regulatory Affairs Manager Ambu, Incorporated 611 North Hammonds Ferry Road Linthicum, Maryland 21090-1356

Re: K040991

Trade/Device Name: Ambu Disposable Pressure Manometer Regulation Number: 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: July 7, 2004 Received: July 8, 2004

Dear Mr. Parikh:

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 approvisions 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 Eederal Register.

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Page 2 - Mr. Parikh

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 mean that I Drimas made statutes and regulations administered by other Federal agencies. or the receively 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 and ifome (21 Cert 6 rth in the quality systems (QS) regulation (21 CFR Part 820); and if requirely as 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) I mis feter mification. The FDA finding of substantial equivalence of your device to a premaired fourted onedicate 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), n you deents 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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 (if known):

Device Name: Ambu Disposable Pressure Manometer

Indications For Use:

Ambu Disposable Pressure Manometer will be used to provide visual indication of the Amou Disposable Prossure Managers and the may be attached to the manoneter port on patient s an way pressure daming venting bags, hyperinflation bags, CPAP Mask or CPAP Circuits.

X Prescription Use _ (Part 21 CFR 801 Subpart D) (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)

K040991 Cluy Julion

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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