Nuubo System
Nuubo30 SIII Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
4manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). 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 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Creative Industry Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Biox Instruments Co Ltd | Wuxi | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Smart Solutions Technologies SL, Spain |
|---|---|
| FDA product code | DSH |
| Device type | Recorder, Magnetic Tape, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| 510(k) | K173461 |
| Record published | 2019-11-15 |
| Record revised | 2024-06-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 45 °C; Storage environment humidity 10 to 95 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2021 | In distribution | |
| 2022 | In distribution | |
| 2020 | In distribution | |
| 2140 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 33 |
| Matrix Wearable | Global Instrumentation, LLC | 12 |
| CardioSTAT | Icentia Inc | 6 |
| Holter ECG and ABP System | Edan Instruments, Inc. | 5 |
| Epatch Sensor | Braemar Manufacturing, LLC | 5 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 4 |
| VitaloJAK | Vitalograph Ireland Ltd. | 4 |
| Care Assist | Philips Medizin Systeme Böblingen GmbH | 4 |
| AT-Patch | ATsens Co., Ltd. | 3 |
| Cuff ABPMpro without ECG | Somnomedics AG | 3 |
| Vasomedical-Biox™ Arcs S/W Dongle – Mini 1200/1201 2 & 3 CH ECG | Vasomedical, Inc. | 3 |
| ECG Leadwire Set for CM 3000 Series | Getemed Medizin- UND Informationstechnik AG | 3 |
Showing 12 of 122. All products under Recorder, Magnetic Tape, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173461 | 2018-08-03 |
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.