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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, peripheral, electric
510(k) Number K924234
Device Name CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272
Applicant
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND,  NZ
Applicant Contact RICHARD BELGRAVE
Correspondent
FISHER & PAYKEL ELECTRONICS LTD.
25 CARBINE ROAD PANMURE
P.O. BOX 14 348 PANMURE
AUCKLAND, NEW ZEALAND,  NZ
Correspondent Contact RICHARD BELGRAVE
Regulation Number868.2775
Classification Product Code
KOI  
Date Received08/24/1992
Decision Date 05/27/1993
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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