Cleared Traditional

Disposable Pressure Manometer (DPM)

K143148 · Westmed, Inc. · Anesthesiology
Aug 2015
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K143148 is an FDA 510(k) clearance for the Disposable Pressure Manometer (DPM), a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Westmed, Inc. (Tucson, US). The FDA issued a Cleared decision on August 11, 2015, 281 days after receiving the submission on November 3, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number K143148 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2014
Decision Date August 11, 2015
Days to Decision 281 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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