| Device |
respiratory accessory microbial reduction device. |
| Definition |
A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturer’s cleaning instructions. |
| Physical State |
Ozone generator. The device may include additional module(s) to produce other components (e.g., water mist/vapor) mixed with ozone. The device may include sensors (e.g., ozone, or humidity). The device may include hardware and software for ozone concentration control and procedure time / step control |
| Technical Method |
The device generates ozone to reduce bacterial population on CPAP device accessory |
| Target Area |
Not target on human body |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | QXQ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6993
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
