Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K141214 |
Device Name |
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS |
Applicant |
Teleflex Medical, Inc. |
2917 Weck Drive |
Research Triangle Park,
NC
27709
|
|
Applicant Contact |
JAMES A COCHIE |
Correspondent |
Teleflex Medical, Inc. |
2917 Weck Drive |
Research Triangle Park,
NC
27709
|
|
Correspondent Contact |
JAMES A COCHIE |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/12/2014 |
Decision Date | 12/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|