COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES

K043238 · Emg Technology Co., Ltd. · CAF · Jul 6, 2005 · Anesthesiology

Device Facts

• Record ID: K043238
• Device Name: COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
• Applicant: Emg Technology Co., Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Jul 6, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizing kit used as prescribed by a physician for medication in the home or health care facility.

Device Story

The EMG NBA02-XXX is a compressor-driven nebulizer system. It utilizes an electric compressor to generate a stream of compressed air, which is delivered to a nebulizer kit. The airflow creates an aerosol mist from liquid medication placed in the kit, allowing the patient to inhale the medication. The device is intended for use in home or clinical settings under physician prescription. It provides a method for administering respiratory medications to patients, facilitating treatment for various respiratory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Compressor-based nebulizer system; electrical energy source; compact form factor; intended for aerosol medication delivery. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring aerosolized medication delivery as prescribed by a physician. Suitable for use in home or healthcare facility settings.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EMG Technology Company Limited C/O Mr. Leonard Frier Met Laboratories, Incorporated 914 West Patapsco Avenue Baltimore, Maryland 21230

Re: K043238

Trade/Device Name: EMG NBA02-XXX Compressor Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 10, 2005 Received: June 13, 2005

Dear Mr. Frier:

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 Amendinently, or to do word 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 ecuirements 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 (1 Writ), It may of buryers to be of Federal Regulations, Title 21; Parts 800 to 898. In your device ear or router announcements concerning your device in the Federal Register.

JUL 6 - 2005

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## Page 2 -- Mr. Frier

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvised that I Dri o issualites on that your device complies with other requirements mean that IDA nas made a decemmaries and regulations administered by other Federal agencies. of the Act of ally I ederal states and reguirements, including, but not limited to: registration You must comply with an the Fict b required to required to the mart 801); good manufacturing practice and listing (21 CFR Part 807), laceming (21 CFR Pat 820), and if 1 CFR Part 820), and if requirents as set form in the quality by sense (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) This letter will anow you to begin mailoring of substantial equivalence of your device to a premits on the and the PDF Pinalis 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
Venese contact the Office of Compliance at [phone]. Also, please of Com prease contact the Other or Occipital premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clive
Shi-Ling, 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 Statement

510K number: K043238

Device Name: EMG NBA02-XXX Compressor Nebulizer

Indications For Use: The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and modical nooming ared as prescribed by a physician for medication in the home or health care facility.

## (Part 21 CFR 801 Subpart D) Prescription Use XXXX I resempton ose - Annife BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number

Aun Seliom

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

K643238 510(k) Number:_