Cleared Abbreviated

Accu O2 Oxygen Analyzer

K173807 · Precision Medical, Inc. · Anesthesiology
May 2018
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K173807 is an FDA 510(k) clearance for the Accu O2 Oxygen Analyzer, a Analyzer, Gas, Oxygen, Gaseous-phase (Class II — Special Controls, product code CCL), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on May 2, 2018, 138 days after receiving the submission on December 15, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number K173807 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2017
Decision Date May 02, 2018
Days to Decision 138 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCL — Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1720