Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K781600 |
Device Name |
MISTY-OX PREFILLED HUMIDIFIER, DISP. |
Applicant |
DAVCO |
15902 Manufacture Lane |
Huntington Beach,
CA
92649
|
|
Applicant Contact |
Richard E Hart |
Correspondent |
DAVCO |
15902 Manufacture Lane |
Huntington Beach,
CA
92649
|
|
Correspondent Contact |
Richard E Hart |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 09/18/1978 |
Decision Date | 10/31/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|