Cleared Traditional

CADWELL EASYNET OXIMETER MODULE

K061706 · Cadwell Laboratories, Inc. · Anesthesiology
Mar 2007
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K061706 is an FDA 510(k) clearance for the CADWELL EASYNET OXIMETER MODULE, a Oximeter (Class II — Special Controls, product code DQA), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on March 5, 2007, 262 days after receiving the submission on June 16, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K061706 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2006
Decision Date March 05, 2007
Days to Decision 262 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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