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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K920436
Device Name MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact DARYLE PETERSEN
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact DARYLE PETERSEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/03/1992
Decision Date 05/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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