Device Classification Name |
Stimulator, Nerve, Battery-Powered
|
510(k) Number |
K882438 |
Device Name |
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252 |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
25 CARBINE ROAD PANMURE |
P.O. BOX 14 348 PANMURE |
AUCKLAND, NEW ZEALAND,
NZ
|
|
Applicant Contact |
DAVID MILBURN |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
25 CARBINE ROAD PANMURE |
P.O. BOX 14 348 PANMURE |
AUCKLAND, NEW ZEALAND,
NZ
|
|
Correspondent Contact |
DAVID MILBURN |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 06/14/1988 |
Decision Date | 07/18/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|