Cleared Traditional

K192035 - EvaQMax Smoke Evacuation System (FDA 510(k) Clearance)

K192035 · Bio Protech, Inc. · General Hospital
Aug 2019
Decision
30d
Days
Class 2
Risk

K192035 is an FDA 510(k) clearance for the EvaQMax Smoke Evacuation System. This device is classified as a Apparatus, Exhaust, Surgical (Class II - Special Controls, product code FYD).

Submitted by Bio Protech, Inc. (Wonju-Si, KR). The FDA issued a Cleared decision on August 29, 2019, 30 days after receiving the submission on July 30, 2019.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number K192035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2019
Decision Date August 29, 2019
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FYD - Apparatus, Exhaust, Surgical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.5070