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510(k) K192035

EvaQMax Smoke Evacuation System by Bio Protech, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2019
Date Received
July 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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  • K111270 — REUSABLE STIMULATING ELECTRODES (September 13, 2011)
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  • K091248 — MAXEMS, MODELS 1000 AND 2000 (November 30, 2009)
  • K092732 — PROPENCIL ESU PENCIL (November 25, 2009)
  • K092761 — PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C (November 24, 2009)
  • K083148 — TELECTRODE WET GEL ECG ELECTRODE (November 7, 2008)

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  • K173108 — Smoklean (May 18, 2018)
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