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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 K883868
Device Name MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
Applicant
Fisher & Paykel Electronics , Ltd.
25 Carbine Rd. Panmure
P.O. Box 14 348 Panmure
Auckland, New Zealand,  NZ
Applicant Contact DAVID MILBURN
Correspondent
Fisher & Paykel Electronics , Ltd.
25 Carbine Rd. Panmure
P.O. Box 14 348 Panmure
Auckland, New Zealand,  NZ
Correspondent Contact DAVID MILBURN
Regulation Number868.2775
Classification Product Code
BXN  
Date Received09/13/1988
Decision Date 11/28/1988
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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