Cleared Traditional

VITAL SIGNS MONITOR

K112465 · Advanced Instruments, Inc. · Anesthesiology
Sep 2011
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K112465 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR, a Oximeter (Class II — Special Controls, product code DQA), submitted by Advanced Instruments, Inc. (Hialeah, US). The FDA issued a Cleared decision on September 14, 2011, 19 days after receiving the submission on August 26, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K112465 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2011
Decision Date September 14, 2011
Days to Decision 19 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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