Description
Description:
The ultrasonic nebulizer, MODEL, NE-520 is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The Medicine Cup contains the nebulizing module where aerosol will be generated. Medication is placed in the Cup, nebulized and inhaled via the integral mouthpiece.
The Medicine Cup is single patient, multi-use. Cleaning is performed afer each use by rinsing with distilled water and disinfected via immersion in boiled water for 10 minutes. The performance met its specificationcriteria of 90 days.
The cup medication capacity is 8 ml.
The Main Unit contains the 2 “AA” batteries or AC Adaptor and firmware to control the vibrating module in the Medicine Cup.
The ultrasonic nebulizer, MODEL, NE-520 aerosolizes upon turning on by pressing the powver button and turns off by pressing again or automatically after treatment completion in 20 minutes. To monitor nebulization status and device operating condition, there are different LED colors shown.
| Proprietary 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: | HONG KONG LANLI TECHNOLOGY CO., LIMITED |
| Registered Establishment Number: | – |
| Premarket Submission Number: | K002153 |
| Owner/Operator: | HONG KONG LANLI TECHNOLOGY CO., LIMITED |
| Owner/Operator Number: | 10092134 |
| Establishment Operations: | Remanufacturer; Repackager/Relabeler |
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