Oximeter
The FDA filing lists models AOJ-70A through AOJ-70E under its Pulse Oximeter name. Its probe shines red and infrared light through tissue, and a photodetector detects transmitted light for…
The FDA filing lists models AOJ-70A through AOJ-70E under its Pulse Oximeter name. Its probe shines red and infrared light through tissue, and a photodetector detects transmitted light for the oxygen-saturation calculation.
The device is described as reusable, finger-applied, and powered by two AAA batteries. Its stated use is spot-checking oxygen saturation and pulse rate in adults in healthcare environments.
Construction and Measurement
The FDA summary names the probe, electronic circuits, display, and plastic enclosure as device components. It also describes LEDs and a light detector in the probe.
Who Else Makes It
Concentrated in Guangdong (46), Jiangsu (7), Beijing (5). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Beijing Kingst Commercial & Trade Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Showing 12 of 70. All 70 manufacturers in China registered for Oximeter
Record
| Listed by | Shenzhen AOJ Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K202173 |
| Record published | 2021-01-26 |
| Record revised | 2021-11-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Inner carton of 4, outer box of 48, color box, outer box of 120, 10845717013557 of 48 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AOJ-70B | In distribution | |
| AOJ-70C | In distribution | |
| AOJ-70E | In distribution | |
| AOJ-70C | In distribution | |
| AOJ-70C | In distribution | |
| AOJ-70C | In distribution | |
| AOJ-70D | In distribution | |
| AOJ-70B | In distribution | |
| AOJ-70C | In distribution | |
| AOJ-70A | In distribution | |
| AOJ-70A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 2,838 |
| APK | APK Technology Co., Ltd. | 2,678 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 151 |
| Nellcor | Covidien LP | 138 |
| Nonin | Nonin Medical, Inc. | 129 |
| Orantech | Orantech Inc. | 97 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 93 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Medichoice | Owens & Minor Distribution, Inc. | 62 |
| Caremed | Shenzhen Caremed Medical Technology Co., Ltd. | 55 |
| Sensoronics | Sensoronics Incorporated | 53 |
| Virtuox | Healthcare Logistics Systems | 36 |
Showing 12 of 1,063. All products under Oximeter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232989 | 2024-07-01 |
| K202173 | 2020-12-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.