Cleared Abbreviated

K063096 - PRECISION OXYGEN MONITOR
(FDA 510(k) Clearance)

K063096 · Precision Medical, Inc. · Anesthesiology
Feb 2007
Decision
140d
Days
Class 2
Risk

K063096 is an FDA 510(k) clearance for the PRECISION OXYGEN MONITOR, 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 February 27, 2007, 140 days after receiving the submission on October 10, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number K063096 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2006
Decision Date February 27, 2007
Days to Decision 140 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