Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K112824 |
Device Name |
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER |
Applicant |
QUALITY LIFE TECHNOLOGIES CO;LTD |
3500 S.DUPONT HIGHWAY |
DOVER,
DE
19901
|
|
Applicant Contact |
LEON LU |
Correspondent |
QUALITY LIFE TECHNOLOGIES CO;LTD |
3500 S.DUPONT HIGHWAY |
DOVER,
DE
19901
|
|
Correspondent Contact |
LEON LU |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/28/2011 |
Decision Date | 06/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|