Cleared Traditional

NS 120P-TRS Airway Pressure Gauge

K180510 · Instrumentation Industries, Inc. · Anesthesiology
May 2019
Decision
428d
Days
Class 2
Risk

About This 510(k) Submission

K180510 is an FDA 510(k) clearance for the NS 120P-TRS Airway Pressure Gauge, a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on May 1, 2019, 428 days after receiving the submission on February 27, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number K180510 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2018
Decision Date May 01, 2019
Days to Decision 428 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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