Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K843903 |
Device Name |
HEATED RESPIRATORY HUMIDIFIER MR428 |
Applicant |
FISHER & PAYKEL ALLIED PRODUCTS LTD. |
P.O. BOX 14-348 |
PANMURE , NEW ZEALAND ,
NZ
|
|
Applicant Contact |
DAVID MILBURN |
Correspondent |
FISHER & PAYKEL ALLIED PRODUCTS LTD. |
P.O. BOX 14-348 |
PANMURE , NEW ZEALAND ,
NZ
|
|
Correspondent Contact |
DAVID MILBURN |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 10/03/1984 |
Decision Date | 10/22/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|