Masimo SpO2b Module W/ Cable & Sensor
Catalogue number 115-047244-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Catheter, Oximeter, Fiber-Optic. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | DQE |
| Device type | Catheter, Oximeter, Fiber-Optic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1230 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K182075 |
| Record published | 2020-05-07 |
| Record revised | 2021-11-10 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115-047244-00 | In distribution |
Same Product Code
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| HemoSphere | Edwards Lifesciences Technology Sarl | 5 |
| Swan-Ganz True Size | Edwards Lifesciences Technology Sarl | 3 |
| HemoSphere Alta | Edwards Lifesciences Technology Sarl | 3 |
| Flotrac | Edwards Lifesciences Technology Sarl | 3 |
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| ForeSight IQ | Edwards Lifesciences Technology Sarl | 1 |
| Pediasat | Edwards Lifesciences Technology Sarl | 1 |
Showing 12 of 18. All products under Catheter, Oximeter, Fiber-Optic
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.