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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number868.2775
Classification Product Code
BXN  
Date Received07/12/1985
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
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