|
|
| Device |
nebulizer (direct patient interface) |
| Regulation Description |
Nebulizer. |
| Product Code | CAF |
| Regulation Number |
868.5630
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ADHERIUM (NZ), LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
6
|
| AEROGEN, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| AIREHEALTH, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BREATHESUITE, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| COGNITA LABS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ENCHANT TEK CO. , LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EXCELLENTCARE MEDICAL (HUIZHOU) , LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FEELLIFE HEALTH, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FISHER & PAYKEL HEALTHCARE LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GLOBALCARE MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HCMED INNOVATIONS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| JOYTECH HEALTHCARE CO. , LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MANKIND PHARMA LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDLINE INDUSTIRES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDLINE INDUSTRIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDLINE INDUSTRIES, LP |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| MONAGHAN MEDICAL CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OCHSNER CLINIC FOUNDATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
1. K223367 Ochsner Connected Inhaler Sensor
|
| PARI RESPIRATORY EQUIPMENT, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| RECIPROCAL LABS CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHENZHEN HOMED MEDICAL DEVICE CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHENZHEN IVANKACA TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHENZHEN JERMEI MEDICAL DEVICE TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| THAYER MEDICAL CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| THE RITEDOSE CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TRUDELL MEDICAL INTERNATIONAL |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| VAPOTHERM, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VOLUNTIS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|
