Soft Sensor Small WO2 Model 8000SS-WO2
Model 8000SS-WO2, Soft Sensor Small WO2, Philips, Reusable Pulse Oximetry Soft Sensor
70manufacturers in China registered for this device type
1catalogue number
42510(k) clearances naming this product code
3recalls on this code
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 | Nonin Medical, Inc., United States |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K092101 |
| Record published | 2021-04-05 |
| Record revised | 2021-11-10 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8000SS-WO2 | 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 |
|---|---|
| K192900 | 2020-06-29 |
| K191403 | 2019-12-20 |
| K172625 | 2018-05-11 |
| K160231 | 2016-12-23 |
| K160865 | 2016-08-05 |
| K140785 | 2014-07-07 |
| K132402 | 2014-02-21 |
| K131021 | 2013-09-11 |
| K112843 | 2012-04-19 |
| K102350 | 2010-12-22 |
| K093853 | 2010-06-04 |
| K093306 | 2010-03-04 |
| K092101 | 2009-10-21 |
| K092678 | 2009-10-01 |
| K081285 | 2008-06-05 |
| K080255 | 2008-05-23 |
| K071415 | 2007-08-08 |
| K071285 | 2007-07-12 |
| K063752 | 2007-05-04 |
| K053130 | 2006-01-11 |
| K052669 | 2005-12-23 |
| K052829 | 2005-11-10 |
| K050056 | 2005-06-21 |
| K051107 | 2005-06-01 |
| K043359 | 2005-01-07 |
| K041156 | 2004-06-09 |
| K040589 | 2004-06-03 |
| K033307 | 2004-05-06 |
| K030668 | 2003-10-17 |
| K023044 | 2003-07-23 |
| K013319 | 2002-01-03 |
| K002690 | 2000-10-11 |
| K001930 | 2000-07-20 |
| K001085 | 2000-05-01 |
| K945290 | 1997-02-11 |
| K942248 | 1994-12-08 |
| K940463 | 1994-03-14 |
| K910001 | 1991-07-18 |
| K893221 | 1990-02-28 |
| K890033 | 1989-02-06 |
| K874947 | 1988-02-12 |
| K860051 | 1986-06-05 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-09-29 | Class II | Process control | Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated m | 15 (11 US; 4 OUS) | 2018-03-12 |
| 2014-11-25 | Class II | Nonconforming Material/Component | Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or il | 5892 (5452 US, 440 OUS) | 2015-09-01 |
| 2007-10-11 | Not classified | Error in labeling | Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500. | 240 | 2011-12-18 |
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.