Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K951683 |
Device Name |
A-V IMPULSE SYSTEM MODEL 6060 |
Applicant |
NOVAMEDIX LTD. |
SIXTH FLOOR |
1001 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
WILLIAM H.E. VON OEHSEN |
Correspondent |
NOVAMEDIX LTD. |
SIXTH FLOOR |
1001 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
WILLIAM H.E. VON OEHSEN |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 04/11/1995 |
Decision Date | 10/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|