Device Classification Name |
warmer, blood, non-electromagnetic radiation
|
510(k) Number |
K973741 |
Device Name |
BAIR HUGGER BLOOD/FLUID WARMER |
Applicant |
AUGUSTINE MEDICAL, INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
SCOTT D AUGUSTINE |
Correspondent |
AUGUSTINE MEDICAL, INC. |
10393 WEST 70TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
SCOTT D AUGUSTINE |
Regulation Number | 864.9205
|
Classification Product Code |
|
Date Received | 10/01/1997 |
Decision Date | 04/30/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|