Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K060865 |
FOIA Releasable 510(k) |
K060865
|
Device Name |
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 |
Applicant |
ARIZANT HEALTHCARE INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
DAVID WESTLIN |
Correspondent |
ARIZANT HEALTHCARE INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
DAVID WESTLIN |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 03/30/2006 |
Decision Date | 04/24/2006 |
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
|
|
|