Data / Medical devices / China / Shenzhen Aeon Technology Co.,ltd
Shenzhen Aeon Technology Co.,ltd: FDA-registered device maker in shenzhen Guangdong, China, 4 510(k) clearances
Shenzhen Aeon Technology Co.,ltd is registered with the FDA (registration 3008830133) in shenzhen Guangdong, China. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 23, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008830133
- Address
- A301, Building A, No. 5003, Bao'an Avenue Bao'an District, shenzhen Guangdong, China, 518126
- Owner or operator
- SHENZHEN AEON TECHNOLOGY CO.,LTD (10052918)
- Roles
- Manufacturer
- First device listed
- October 18, 2016
- Registered through
- 2026
- Brand names listed
- Compressor Nebulizer A500LWD01,A500LWD02,A500LWD04,A500LWD05,A500LWDC01,A500LWDC02,A500LWDC04,A500LWDC05, Electronic Thermometer A260, A261, A262, A263, A264, A265, Fingertip Pulse Oximeter A310B, A330B, A340B, Fingertip pulse oximeter A300,A310,A320,A330,A340,A350,A310L,A330N,A340L,A310E, Fingtip Pulse Oximeter A310, Infrared Thermometer A200,A201,A202,A201F,A201W,A202W,A202C,A202D,A202E,A202F, Pulse Oximeter A310E, A320E, A330E, A340E, A310, A350, A350E, A370E, A371E, AIMO1, AIMO2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2020 | K200414 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Aeon Technology Co., Ltd. | accessdata.fda.gov |
| September 13, 2019 | K190869 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Aeon Technology Co., Ltd. | accessdata.fda.gov |
| November 30, 2017 | K171578 | Infrared thermometer | FLL | Substantially Equivalent | Shenzhen Aeon Technology Co., Ltd. | accessdata.fda.gov |
| November 22, 2016 | K153021 | Fingertip Pulse Oximeter A310 | DQA | Substantially Equivalent | Amemo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Clinical Electronic Thermometer
- All makers of Continuous Measurement Thermometer
- All makers of Oximeter
- All makers of Compressor, Air, Portable
- All makers of Oximeter, Infrared, Sporting, Aviation
Updated September 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.