Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K152276 |
Device Name |
Wing Smart FEVI and Peak Flow Meter |
Applicant |
Sparo Inc. |
911 Washington Ave, #809 |
Saint Louis,
MO
63101
|
|
Applicant Contact |
Mona Dean |
Correspondent |
Sparo Inc. |
911 Washington Ave, #809 |
Saint Louis,
MO
63101
|
|
Correspondent Contact |
Mona Dean |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 08/12/2015 |
Decision Date | 06/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|