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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K945286
Device Name THE BAGNOLI-2 EMG SYSTEM
Applicant
Delsys, Inc.
30 Yarmouth Rd.
Wellesley,  MA  02181
Applicant Contact CARLO J DE LUCA
Correspondent
Delsys, Inc.
30 Yarmouth Rd.
Wellesley,  MA  02181
Correspondent Contact CARLO J DE LUCA
Regulation Number882.5050
Classification Product Code
HCC  
Date Received10/31/1994
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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