Device Classification Name |
flowmeter, blood, cardiovascular
|
510(k) Number |
K213974 |
Device Name |
GEM FLOW COUPLER Monitor (GEM1020M-2) |
Applicant |
Synovis Micro Companies Alliance, Inc. |
(a Subsidiary of Baxter International Inc.) |
439 Industrial Lane |
Birmingham,
AL
35211
|
|
Applicant Contact |
Russell Pagano |
Correspondent |
Synovis Micro Companies Alliance, Inc. |
(a Subsidiary of Baxter International Inc.) |
439 Industrial Lane |
Birmingham,
AL
35211
|
|
Correspondent Contact |
Julie S. Carlston |
Regulation Number | 870.2100
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2021 |
Decision Date | 04/20/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|