Device Classification Name |
flowmeter, blood, cardiovascular
|
510(k) Number |
K191388 |
Device Name |
FloPatch (FP110) |
Applicant |
Flosonics Medical (r/a 1929803 Ontario Corp.) |
204-73 Elm Street |
Sudbury,
CA
P3C 1R7
|
|
Applicant Contact |
Joe Eibl |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 870.2100
|
Classification Product Code |
|
Date Received | 05/24/2019 |
Decision Date | 06/21/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|