FDA 510(k) Application Details - K152585

Device Classification Name

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510(K) Number K152585
Device Name Resmon PRO FULL
Applicant MEDICAL GRAPHICS CORP.
350 OAK GROVE PARKWAY
ST. PAUL, MN 55127 US
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Contact JIM PURDIE
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Regulation Number

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Classification Product Code PNV
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Date Received 09/10/2015
Decision Date 06/24/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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