Cleared Traditional

PRESSURE MANOMETER

K110119 · Neoforce Group, Inc. · Anesthesiology
Jun 2011
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K110119 is an FDA 510(k) clearance for the PRESSURE MANOMETER, a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Neoforce Group, Inc. (Ivyland, US). The FDA issued a Cleared decision on June 10, 2011, 143 days after receiving the submission on January 18, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number K110119 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2011
Decision Date June 10, 2011
Days to Decision 143 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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