FDA 510(k) Application Details - K171188

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K171188
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant LR Med Inc
1450, Tomlin Drive Burr Ridge
Burr Ridge, IL 60527 US
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Contact Prashant Deshpande
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 04/24/2017
Decision Date 06/23/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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