Search Results
Found 2 results
510(k) Data Aggregation
(263 days)
The portable mesh nebulizer is intended to aerosolize medicine liquid for inhalation by the patient. The device is used with adult and pediatric (≥3 years old) both in hospital, home, and sub-acute settings.
It is not intended for use with Pentamidine.
JM821 portable mesh nebulizer is a portable vibrating mesh nebulizer, which incorporates a piezoelectric transducer that vibrates at a nominal frequency when electrical current is applied. It is designed to nebulize liquid medications into fine particulates for inhalation by a patient, so as to therapy respiratory diseases.
The subject device is portable size, handheld design, it is powered by a 3.7V d.c. internally lithium battery, which is charged by an adapter.
The subject device does not contain any medicine. Only use physician-prescribed solutions that are approved for use with a general-purpose nebulizer. Consult drug manufacturer's instructions regarding suitability for nebulization.
The portable mesh nebulizer is single-patient, multiple-use. The mask can be can used for 30 sessions of aerosol treatment.
N/A
Ask a specific question about this device
(711 days)
The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient. It is not intended for use with Pentamidine.
Vibrating Mesh Nebulizer System
I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving a device meets acceptance criteria.
The document is an FDA 510(k) clearance letter for a "Portable Mesh Nebulizer" and primarily focuses on:
- The FDA's review and determination of substantial equivalence.
- Regulatory requirements for the device.
- Instructions for use, patient population, and environment of use for the device.
Therefore, I cannot fulfill your request based on the given input.
Ask a specific question about this device
Page 1 of 1