Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K003561 |
Device Name |
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 |
Applicant |
INVACARE CORP. |
ONE INVACARE WAY |
ELYRIA,
OH
44036 -2125
|
|
Applicant Contact |
RAE ANN FARROW |
Correspondent |
INVACARE CORP. |
ONE INVACARE WAY |
ELYRIA,
OH
44036 -2125
|
|
Correspondent Contact |
RAE ANN FARROW |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 11/20/2000 |
Decision Date | 04/17/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|