Medke
The Medke Oximetry Finger Sensor filing names P9119 and P8119 as subject-device models. It describes the product as a compatible sensor for use with patient monitors and oximeter devices.…
The Medke Oximetry Finger Sensor filing names P9119 and P8119 as subject-device models. It describes the product as a compatible sensor for use with patient monitors and oximeter devices.
The stated indication is continuous, non-invasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult patients weighing more than 40 kg.
Listed Item
Nellcor Oximax Compatible SpO2 Sensor Adult/Neonate Disposable/Single Patient Use – 36″ cable Box of 24 Comparable to MAX-N
Optical Sensing
The filing describes two wavelength LEDs and a photodetector. Connected between the patient and an oximeter, the sensors use optical means to determine light absorption by functional arterial hemoglobin.
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 Medke Technology Co., Ltd., China |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Manufacturer |
| 510(k) | K152390 |
| Record published | 2023-10-24 |
| Record revised | 2023-10-26 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P1319D-01 | In distribution | |
| P1119-01 | In distribution | |
| P9318E | In distribution | |
| P8119A | In distribution | |
| P1419-01 | In distribution | |
| P11219-01 | In distribution | |
| P11819-01 | In distribution | |
| P1019-01 | In distribution | |
| P11419-01 | In distribution | |
| P1619-01 | In distribution | |
| P11719-01 | In distribution | |
| P12319-01 | In distribution | |
| P1719-01 | In distribution | |
| P1819-01 | In distribution | |
| P9119 | In distribution | |
| P1519-01 | In distribution | |
| P1919-01 | In distribution | |
| P12419-01 | In distribution | |
| P1219-01 | In distribution | |
| P1019-01 | In distribution | |
| P11319-01 | In distribution | |
| P11919-01 | In distribution | |
| P1719-01 | In distribution | |
| P11519-01 | In distribution | |
| P12119-01 | In distribution | |
| P11119-01 | In distribution | |
| P11019-01 | In distribution | |
| P11619-01 | In distribution | |
| P1319-01 | In distribution | |
| P12019-01 | In distribution | |
| P4110C | In distribution | |
| P8119 | In distribution | |
| P9119A | In distribution | |
| P1315F-01BC | In distribution | |
| P12219-01 | 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 |
|---|---|
| K152390 | 2016-08-18 |
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.