Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K892817 |
Device Name |
HEATED RESPIRATORY HUMIDIFIER |
Applicant |
FISHER & PAYKEL ELECTRONICS LTD. |
25 CARBINE ROAD PANMURE |
P.O. BOX 14 348 PANMURE |
AUCKLAND, NEW ZEALAND,
NZ
|
|
Applicant Contact |
RICHARD BELGRAVE |
Correspondent |
FISHER & PAYKEL ELECTRONICS LTD. |
25 CARBINE ROAD PANMURE |
P.O. BOX 14 348 PANMURE |
AUCKLAND, NEW ZEALAND,
NZ
|
|
Correspondent Contact |
RICHARD BELGRAVE |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 04/17/1989 |
Decision Date | 12/21/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|