Device Classification Name |
analyzer, gas, oxygen, gaseous-phase
|
510(k) Number |
K963415 |
Device Name |
VENTREX OXYGEN SENSOR |
Applicant |
VENTREX, LLC. |
159 GIBRALTAR RD. |
HORSHAM,
PA
19044
|
|
Applicant Contact |
MARY HUEGEL |
Correspondent |
VENTREX, LLC. |
159 GIBRALTAR RD. |
HORSHAM,
PA
19044
|
|
Correspondent Contact |
MARY HUEGEL |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 08/30/1996 |
Decision Date | 11/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|