Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K200225 |
Device Name |
Arctic Sun Stat Temperature Management System |
Applicant |
Medivance, Inc. |
321 South Taylor Ave, Suite 200 |
Louisville,
CO
80027
|
|
Applicant Contact |
Jacquelyn Borinski |
Correspondent |
Medivance, Inc. |
321 South Taylor Ave, Suite 200 |
Louisville,
CO
80027
|
|
Correspondent Contact |
Jacquelyn Borinski |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 01/30/2020 |
Decision Date | 02/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|