Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K953949 |
Device Name |
HUMIDIFIER & ACCESSORIES |
Applicant |
FISHER & PAYKEL ELECTRONICS LTD. |
25 CARBINE ROAD PANMURE |
P.O. BOX 14 348 PANMURE |
AUCKLAND, NEW ZEALAND,
NZ
|
|
Applicant Contact |
ADELE YEE |
Correspondent |
FISHER & PAYKEL ELECTRONICS LTD. |
25 CARBINE ROAD PANMURE |
P.O. BOX 14 348 PANMURE |
AUCKLAND, NEW ZEALAND,
NZ
|
|
Correspondent Contact |
ADELE YEE |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 08/22/1995 |
Decision Date | 10/16/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|