Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K010402 |
Device Name |
SMOOTH-FLO CIRCUIT |
Applicant |
HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. |
P.O. BOX 9020 |
TEMECULA,
CA
92589 -9020
|
|
Applicant Contact |
CHARLES MIERKIEWICZ |
Correspondent |
HUDSON RESPIRATORY CARE, INC. |
27711 DIAZ RD. |
P.O. BOX 9020 |
TEMECULA,
CA
92589 -9020
|
|
Correspondent Contact |
CHARLES MIERKIEWICZ |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 02/12/2001 |
Decision Date | 03/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|