Device Classification Name |
system, thermal regulating
|
510(k) Number |
K200446 |
Device Name |
STERIS Patient Warming System |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
Gregory Land |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
Gregory Land |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 02/24/2020 |
Decision Date | 06/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|