Cleared Traditional

SECHRIST AIRWAY PRESSURE MONITOR #400

K810648 · Sechrist Industries, Inc. · Anesthesiology
Mar 1981
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K810648 is an FDA 510(k) clearance for the SECHRIST AIRWAY PRESSURE MONITOR #400, a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Sechrist Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 20, 1981, 9 days after receiving the submission on March 11, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number K810648 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1981
Decision Date March 20, 1981
Days to Decision 9 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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

Similar Devices — CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 77
SINGLE USE MANOMETER
K201666 · Flexicare Medical Limited. · Nov 2020
VORTRAN APM-Plus
K182292 · Vortran Medical Technology 1, Inc. · Sep 2019
NS 120P-TRS Airway Pressure Gauge
K180510 · Instrumentation Industries, Inc. · May 2019
NAPA LP-15 Airway Pressure Monitor
K172284 · Drw Medical, LLC · Feb 2018
VORTRAN Manometer
K153733 · Vortran Medical Technology 1, Inc. · Sep 2016
Disposable Pressure Manometer (DPM)
K143148 · Westmed, Inc. · Aug 2015