Cleared Traditional

1500 SERIES REGULATOR

K932006 · Precision Medical, Inc. · Anesthesiology
Oct 1993
Decision
187d
Days
Class 1
Risk

About This 510(k) Submission

K932006 is an FDA 510(k) clearance for the 1500 SERIES REGULATOR, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on October 25, 1993, 187 days after receiving the submission on April 21, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number K932006 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 1993
Decision Date October 25, 1993
Days to Decision 187 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAN — Regulator, Pressure, Gas Cylinder
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2700

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