Cleared Traditional

SECHRIST AIRWAY PRESSURE MONITOR MODEL 600

K861330 · Sechrist Industries, Inc. · Anesthesiology
Apr 1986
Decision
2d
Days
Class 2
Risk

About This 510(k) Submission

K861330 is an FDA 510(k) clearance for the SECHRIST AIRWAY PRESSURE MONITOR MODEL 600, a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on April 11, 1986, 2 days after receiving the submission on April 9, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number K861330 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1986
Decision Date April 11, 1986
Days to Decision 2 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

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