Device Classification Name |
system, thermal regulating
|
510(k) Number |
K142702 |
Device Name |
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad |
Applicant |
MEDIVANCE, INC. |
321 SOUTH TAYLOR AVENUE |
SUITE 200 |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
Stacci Cronk |
Correspondent |
MEDIVANCE, INC. |
321 SOUTH TAYLOR AVENUE |
SUITE 200 |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
Stacci Cronk |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 12/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|