Device Classification Name |
warmer, thermal, infusion fluid
|
510(k) Number |
K180842 |
Device Name |
MAC Medical D-Series Blanket and Solution Warming Cabinets |
Applicant |
MAC Medical Inc. |
820 S Mulberry |
Millstadt,
IL
62260
|
|
Applicant Contact |
Dennis Cooper |
Correspondent |
MAC Medical Inc. |
820 S Mulberry |
Millstadt,
IL
62260
|
|
Correspondent Contact |
Gary Oliveros |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/30/2018 |
Decision Date | 03/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|