Device Classification Name |
Condenser, Heat And Moisture (Artificial Nose)
|
510(k) Number |
K945657 |
Device Name |
DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER |
Applicant |
TEC II MEDICAL, INC. |
1 S 241 NORTH FLANDERS LN. |
WINFIELD,
IL
60190
|
|
Applicant Contact |
CHARLES COSENTINO |
Correspondent |
TEC II MEDICAL, INC. |
1 S 241 NORTH FLANDERS LN. |
WINFIELD,
IL
60190
|
|
Correspondent Contact |
CHARLES COSENTINO |
Regulation Number | 868.5375
|
Classification Product Code |
|
Date Received | 11/17/1994 |
Decision Date | 12/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|