Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K130379 |
Device Name |
ROLLINS 7 OXYGEN MASK |
Applicant |
ROLLINS MEDICAL SOLUTIONS, INC. |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Applicant Contact |
E. J SMITH |
Correspondent |
ROLLINS MEDICAL SOLUTIONS, INC. |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Correspondent Contact |
E. J SMITH |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/14/2013 |
Decision Date | 10/09/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|