Cleared Traditional

PRESSURE GAUGE

K853040 · Erie Medical · Anesthesiology
Oct 1985
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K853040 is an FDA 510(k) clearance for the PRESSURE GAUGE, a Gauge, Gas Pressure, Cylinder/pipeline (Class I — General Controls, product code BXH), submitted by Erie Medical (Milwaukee, US). The FDA issued a Cleared decision on October 10, 1985, 83 days after receiving the submission on July 19, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2610.

Submission Details

510(k) Number K853040 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1985
Decision Date October 10, 1985
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BXH — Gauge, Gas Pressure, Cylinder/pipeline
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2610