Cleared Traditional

PRESSURE REGULATOR

K853039 · Erie Medical · Anesthesiology

Apr 1986

Decision

266d

Days

Class 1

Risk

About This 510(k) Submission

K853039 is an FDA 510(k) clearance for the PRESSURE REGULATOR, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Erie Medical (Milwaukee, US). The FDA issued a Cleared decision on April 11, 1986, 266 days after receiving the submission on July 19, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number	K853039 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 1985
Decision Date	April 11, 1986
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—