Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K121969 |
Device Name |
U-RIGHT COMPRESSOR NEBULIZER |
Applicant |
TaiDoc Technology Corporation |
3F,5F, No.127, Wugong 2nd Rd. |
Wugu District |
New Taipei City,
TW
24888
|
|
Applicant Contact |
PINJUNG CHEN |
Correspondent |
TaiDoc Technology Corporation |
3F,5F, No.127, Wugong 2nd Rd. |
Wugu District |
New Taipei City,
TW
24888
|
|
Correspondent Contact |
PINJUNG CHEN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/05/2012 |
Decision Date | 02/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|