Description of Device:
The Ultrasonic Nebulizer, Model NE-520 is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen nebulizers. The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies and provide fine particles to the patient's lungs. The Ultrasonic Nebulizer, Model NE-520 is powered by a cable connecting to a 120 VAC power source with the AC adapter or two AA alkaline batteries.
Intended Use:
The Ultrasonic Nebulizer, Model NE-520 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.
Technological Characteristics:
The Ultrasonic Nebulizer, Model NE-520 utilizes ceramic resonator and mesh plate to transform liquid medications into aerosol form and deliver fine particles to the patients. The device is powered by two AA type batteries which make it ultra-light and quiet compared with traditional compressor and ultrasonic nebulizer.
510(k) Number: K002153
Device Name: ULTRASONIC NEBULIZER, MODEL NE-520
Manufacturer: HENGSHENG INDUSTRY CO., LIMITED
| Device Name: | Ultrasonic Nebulizer, Model: NE-520 |
| Classification Name: | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code: | CAF |
| Device Class: | 2 |
| Regulation Number: | 868.5630 |
| Medical Specialty: | Anesthesiology |
| Registered Establishment Name: | HENGSHENG INDUSTRY CO., LIMITED |
| Registered Establishment Number: | 3031700049 |
| Premarket Submission Number: | K002153 |
| Owner/Operator: | HENGSHENG INDUSTRY CO., LIMITED |
| Owner/Operator Number: | 10091155 |
| Establishment Operations: | Repackager/Relabeler |
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