Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K140772 |
Device Name |
AEROSURE MEDIC |
Applicant |
Actegy Ltd |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
John j Smith, M.D., J.D. |
Correspondent |
HOGAN LOVELLS US LLP |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
John j Smith, M.D., J.D. |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 03/27/2014 |
Decision Date | 12/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|