FDA 510(k) Application Details - K150687

Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems

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510(K) Number K150687
Device Name Monitor, Electric For Gravity Flow Infusion Systems
Applicant Shift Labs
1752 NW Market St.#211
Seattle, WA 98107 US
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Contact Beth Kolko
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Regulation Number 880.2420

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Classification Product Code FLN
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Date Received 03/17/2015
Decision Date 10/13/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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