Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K955010 |
Device Name |
AUTOVAC BP SYSTE, 2000 SERIES |
Applicant |
BOEHRINGER LABORATORIES |
500 E. WASHINGTON ST. |
NORRISTOWN,
PA
19401
|
|
Applicant Contact |
JOHN KARPOWICZ |
Correspondent |
BOEHRINGER LABORATORIES |
500 E. WASHINGTON ST. |
NORRISTOWN,
PA
19401
|
|
Correspondent Contact |
JOHN KARPOWICZ |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 11/01/1995 |
Decision Date | 06/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|