Device Classification Name |
Accessory To Continuous Ventilator (Respirator)
|
510(k) Number |
K011861 |
Device Name |
BERNOULLI VENTILATOR MANAGEMENT SYSTEM |
Applicant |
CARDIOPULMONARY CORP. |
200 CASCADE BLVD. |
MILFORD,
CT
06460
|
|
Applicant Contact |
JOHN LAVIOLA |
Correspondent |
CARDIOPULMONARY CORP. |
200 CASCADE BLVD. |
MILFORD,
CT
06460
|
|
Correspondent Contact |
JOHN LAVIOLA |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/14/2001 |
Decision Date | 11/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|