Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K945775 |
Device Name |
BOEHRINGER AUTOVAC(R) 7900 SERIES |
Applicant |
BOEHRINGER LABORATORIES |
P.O. BOX 870 |
NORRISTOWN,
PA
19404
|
|
Applicant Contact |
JOHN KARPOWICZ |
Correspondent |
BOEHRINGER LABORATORIES |
P.O. BOX 870 |
NORRISTOWN,
PA
19404
|
|
Correspondent Contact |
JOHN KARPOWICZ |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 11/25/1994 |
Decision Date | 10/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|