Shenzhen Aeon Technology Co., Ltd.

FDA Regulatory Profile

Shenzhen Aeon Technology Co., Ltd. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 1, 2024 · VAI
Latest 510(k)
Sep 23, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 1, 2024Shenzhen, ChinaDevicesVoluntary Action Indicated (VAI)3008830133

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K200414Pulse OximeterSep 23, 2020
K190869Pulse OximeterSep 13, 2019
K171578Infrared thermometerNov 30, 2017