FDA 510(k) Application Details - K963202

Device Classification Name Device, Biofeedback

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510(K) Number K963202
Device Name Device, Biofeedback
Applicant MEGA ELECTRONICS LTD.
1660 RIVERTON POINT
EAGAN, MN 55122 US
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Contact GREGORY J MATHISON
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Regulation Number 882.5050

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Classification Product Code HCC
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Date Received 08/15/1996
Decision Date 05/19/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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