Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K923754 |
Device Name |
MISTY OX LAMINAR DIFFUSER HUMIDIFIER |
Applicant |
MEDICAL MOLDING CORP. OF AMERICA |
240 BRIGGS AVE. |
COSTA MESA,
CA
92626 -4555
|
|
Applicant Contact |
TERRY BAGWELL |
Correspondent |
MEDICAL MOLDING CORP. OF AMERICA |
240 BRIGGS AVE. |
COSTA MESA,
CA
92626 -4555
|
|
Correspondent Contact |
TERRY BAGWELL |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 07/28/1992 |
Decision Date | 12/07/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|