Device Classification Name |
oximeter
|
510(k) Number |
K964821 |
Device Name |
COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 |
Applicant |
VENTREX, INC. |
3007 BUNSEN AVE., UNIT L & K |
VENTURA,
CA
93003
|
|
Applicant Contact |
ROBERT B GUTHRIE |
Correspondent |
VENTREX, INC. |
3007 BUNSEN AVE., UNIT L & K |
VENTURA,
CA
93003
|
|
Correspondent Contact |
ROBERT B GUTHRIE |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/02/1996 |
Decision Date | 07/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|