Cleared Traditional

LOW PRESSURE ALARM FOR OXYGEN CYLINDER

K843212 · Hospitak, Inc. · Anesthesiology

Sep 1984

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K843212 is an FDA 510(k) clearance for the LOW PRESSURE ALARM FOR OXYGEN CYLINDER, a Gauge, Gas Pressure, Cylinder/pipeline (Class I — General Controls, product code BXH), submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 19, 1984, 35 days after receiving the submission on August 15, 1984. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2610.

Submission Details

510(k) Number	K843212 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 1984
Decision Date	September 19, 1984
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—