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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 Rd., Panmure
P.O. Box 14-348, Panmure
Auckland, New Zealand,  NZ
Applicant Contact DAVE MILBURN
Correspondent
Fisher & Paykel Allied Products , Ltd.
25 Carbine Rd., 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
Predetermined Change
Control Plan Authorized		 No
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