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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 K830058
Device Name MYOGRAPH 2000
Applicant
Prothia USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Prothia USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.2775
Classification Product Code
BXN  
Date Received01/07/1983
Decision Date 03/07/1983
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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