FDA 510(k) Application Details - K014019

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K014019
Device Name Stimulator, Muscle, Powered
Applicant BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK,
WEST GALWAY IE
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Contact MICHELLE SAWYER
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 12/06/2001
Decision Date 07/11/2002
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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