Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K943412 |
Device Name |
VENTURI VENTILATOR |
Applicant |
CARDIOPULMONARY CORP. |
200 CASCADE BLVD. |
MILFORD,
CT
06460
|
|
Applicant Contact |
JAMES W BIONDI |
Correspondent |
CARDIOPULMONARY CORP. |
200 CASCADE BLVD. |
MILFORD,
CT
06460
|
|
Correspondent Contact |
JAMES W BIONDI |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 07/14/1994 |
Decision Date | 10/16/1995 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|