Cleared Traditional

Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)

K232989 · Shenzhen AOJ Medical Technology Co., Ltd. · Anesthesiology
Jul 2024
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K232989 is an FDA 510(k) clearance for the Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E), a Oximeter (Class II — Special Controls, product code DQA), submitted by Shenzhen AOJ Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2024, 283 days after receiving the submission on September 22, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K232989 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2023
Decision Date July 01, 2024
Days to Decision 283 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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