Device Classification Name |
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
|
510(k) Number |
K952267 |
Device Name |
CRITERION, CRITERION I.V., MODIFIED |
Applicant |
NOVA-VENTRX |
1974 RAYMOND DR. |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
BERNARD R PALUCH |
Correspondent |
NOVA-VENTRX |
1974 RAYMOND DR. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
BERNARD R PALUCH |
Regulation Number | 868.5270 |
Classification Product Code |
|
Date Received | 05/15/1995 |
Decision Date | 12/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|