Cleared Traditional

PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1

K111617 · Acare Technology Co., Ltd. · Anesthesiology
Dec 2011
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K111617 is an FDA 510(k) clearance for the PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1, a Oximeter (Class II — Special Controls, product code DQA), submitted by Acare Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 22, 2011, 195 days after receiving the submission on June 10, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K111617 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2011
Decision Date December 22, 2011
Days to Decision 195 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

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