Cleared Traditional

VORTRAN Manometer

K153733 · Vortran Medical Technology 1, Inc. · Anesthesiology
Sep 2016
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K153733 is an FDA 510(k) clearance for the VORTRAN Manometer, 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 16, 2016, 263 days after receiving the submission on December 28, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number K153733 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2015
Decision Date September 16, 2016
Days to Decision 263 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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