Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K031383 |
Device Name |
MODEL 780 |
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 | 05/01/2003 |
Decision Date | 07/07/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|