Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K822816 |
Device Name |
DUAL SERVO HEATED RESPIRATORY HUMIDIFIER |
Applicant |
FISHER & PAYKEL ALLIED PRODUCTS LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
FISHER & PAYKEL ALLIED PRODUCTS LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 09/20/1982 |
Decision Date | 10/22/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|