FDA 510(k) Application Details - K200574

Device Classification Name

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510(K) Number K200574
Device Name EksoNR
Applicant Ekso Bionics, Inc.
1414 Harbour Way South, Suite 1201
Richmond, CA 94804 US
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Contact Jack Peurach
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Regulation Number

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Classification Product Code PHL
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Date Received 03/05/2020
Decision Date 06/19/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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