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FDA 510(k)

EvaQMax Smoke Evacuation System

K-Number: K192035 · 2019-08-29

ApplicantBio Protech, Inc.
Decision Date2019-08-29
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EvaQMax Smoke Evacuation System is a medical device manufactured by Bio Protech, Inc.. It received FDA 510(k) clearance on 2019-08-29 under approval number K192035. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EvaQMax Smoke Evacuation System?

EvaQMax Smoke Evacuation System is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Bio Protech, Inc.. The 510(k) number is K192035.

When was EvaQMax Smoke Evacuation System approved by the FDA?

EvaQMax Smoke Evacuation System received FDA 510(k) clearance on 2019-08-29, under approval number K192035.

What company makes EvaQMax Smoke Evacuation System?

EvaQMax Smoke Evacuation System is manufactured by Bio Protech, Inc..

What is the FDA product code for EvaQMax Smoke Evacuation System?

The FDA product code for EvaQMax Smoke Evacuation System is FYD.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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