Device Classification Name |
system, thermal regulating
|
510(k) Number |
K112488 |
Device Name |
HOTDOG PATIENT WARMING SYSTEM |
Applicant |
AUGUSTINE BIOMEDICAL & DESIGN, LLC |
6581 CITY WEST PARKWAY |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
WENDY NELSON |
Correspondent |
AUGUSTINE BIOMEDICAL & DESIGN, LLC |
6581 CITY WEST PARKWAY |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
WENDY NELSON |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 08/29/2011 |
Decision Date | 11/23/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|