Device Classification Name |
warmer, thermal, infusion fluid
|
510(k) Number |
K121198 |
Device Name |
BW685, BW685S |
Applicant |
BIEGLER GMBH |
24301 WOODSAGE DR |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
BIEGLER GMBH |
24301 WOODSAGE DR |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 04/19/2012 |
Decision Date | 07/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|