Device Classification Name |
Stimulator, Nerve, Battery-Powered
|
510(k) Number |
K852962 |
Device Name |
PERIPHERAL NERVE STIMULATOR MODEL A400 |
Applicant |
FISHER & PAYKEL ALLIED PRODUCTS LTD. |
25 CARBINE ROAD, PANMURE |
P.O. BOX 14-348, PANMURE |
AUCKLAND, NEW ZEALAND,
NZ
|
|
Applicant Contact |
DAVE MILBURN |
Correspondent |
FISHER & PAYKEL ALLIED PRODUCTS LTD. |
25 CARBINE ROAD, PANMURE |
P.O. BOX 14-348, PANMURE |
AUCKLAND, NEW ZEALAND,
NZ
|
|
Correspondent Contact |
DAVE MILBURN |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 07/12/1985 |
Decision Date | 12/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|