Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K873745 |
Device Name |
BAIR HUGGER(TM) - PATIENT WARMING SYSTEM |
Applicant |
AUGUSTINE MEDICAL, INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
D AUGUSTINE |
Correspondent |
AUGUSTINE MEDICAL, INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
D AUGUSTINE |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 09/16/1987 |
Decision Date | 11/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|