Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K200832 |
Device Name |
Safey Peak Flow Meter |
Applicant |
Safey Medical Devices Pvt Ltd |
3rd Floor, Office 303, Nyati Emporius, S no 105 H no 4A, |
Baner |
Pune,
IN
411045
|
|
Applicant Contact |
Taher Ali Moiyed |
Correspondent |
Safey Medical Devices Pvt Ltd |
3rd Floor, Office 303, Nyati Emporius, S no 105 H no 4A, |
Baner |
Pune,
IN
411045
|
|
Correspondent Contact |
Taher Ali Moiyed |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 03/30/2020 |
Decision Date | 07/30/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|