Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K172804 |
Device Name |
Besmed Peak Flow Meter |
Applicant |
Besmed Health Business Corp. |
No.5, Lane 116, Wu-Kong 2nd Rd |
Wu-Ku District,
TW
|
|
Applicant Contact |
Lawrence Wu |
Correspondent |
Besmed Health Business Corp. |
No.5, Lane 116, Wu-Kong 2nd Rd |
Wu-Ku District,
TW
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 09/18/2017 |
Decision Date | 01/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|