Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K181660 |
Device Name |
Acapella Choice Blue Vibratory PEP Device |
Applicant |
Smiths Medical |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Applicant Contact |
Donna Semlak |
Correspondent |
MRC-X, LLC |
6075 Poplar Avenue, Suite 500 |
Memphis,
TN
38119
|
|
Correspondent Contact |
Dawn Norman |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 06/25/2018 |
Decision Date | 10/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|