Cleared Traditional

VORTRAN APM-Plus

K182292 · Vortran Medical Technology 1, Inc. · Anesthesiology
Sep 2019
Decision
391d
Days
Class 2
Risk

About This 510(k) Submission

K182292 is an FDA 510(k) clearance for the VORTRAN APM-Plus, a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on September 18, 2019, 391 days after receiving the submission on August 23, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number K182292 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2018
Decision Date September 18, 2019
Days to Decision 391 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAP — Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2600

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