Cleared Traditional

DISPOSABLE PRESSURE MANOMETER

K140370 · Besmed Health Business Corp · Anesthesiology
Jun 2014
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K140370 is an FDA 510(k) clearance for the DISPOSABLE PRESSURE MANOMETER, a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Besmed Health Business Corp (New Taipei City, Wu-Ku District, TW). The FDA issued a Cleared decision on June 19, 2014, 125 days after receiving the submission on February 14, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number K140370 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2014
Decision Date June 19, 2014
Days to Decision 125 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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