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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 K010388
Device Name SONDREX P.A.L. SYSTEM
Applicant
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Applicant Contact ALBERTO F PROFUMO
Correspondent
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Correspondent Contact ALBERTO F PROFUMO
Regulation Number882.5050
Classification Product Code
HCC  
Date Received02/08/2001
Decision Date 12/11/2001
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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