Cleared Traditional

VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC

K103639 · Vortran Medical Technology 1, Inc. · Anesthesiology

Sep 2011

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K103639 is an FDA 510(k) clearance for the VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC, 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 15, 2011, 276 days after receiving the submission on December 13, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number	K103639 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2010
Decision Date	September 15, 2011
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF