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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 K853806
Device Name MA-400 EMB FEEDBACK DEVICE
Applicant
SPECTRAL DATA SYSTEMS
4411 GEARY BLVD. #301
SAN FRANCISCO,  CA  94118
Applicant Contact LARRY WOODARD
Correspondent
SPECTRAL DATA SYSTEMS
4411 GEARY BLVD. #301
SAN FRANCISCO,  CA  94118
Correspondent Contact LARRY WOODARD
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/11/1985
Decision Date 12/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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