FDA 510(k) Application Details - K990813

Device Classification Name Exerciser, Measuring

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510(K) Number K990813
Device Name Exerciser, Measuring
Applicant ELECTROMED CORP.
PO 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 890.5360

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Classification Product Code ISD
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Date Received 03/11/1999
Decision Date 04/12/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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