Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K942844 |
Device Name |
LEVEL 1 BLOOD STREAM RECOVERY SYSTEM |
Applicant |
LEVEL 1 TECHNOLOGIES, INC. |
160 WEYMOUTH ST. |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
WESLEY H VERKAART |
Correspondent |
LEVEL 1 TECHNOLOGIES, INC. |
160 WEYMOUTH ST. |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
WESLEY H VERKAART |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 06/16/1994 |
Decision Date | 04/26/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|