Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K993355 |
Device Name |
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 |
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 | 10/06/1999 |
Decision Date | 05/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|