ECG Cable
Unit;2.5m, ECG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
5manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them 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 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Cnsystems Medizintechnik GmbH, Austria |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Manufacturer |
| 510(k) | K014063 |
| Record published | 2018-11-28 |
| Record revised | 2021-11-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 0 to 40 °C; Storage environment humidity 20 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A | In distribution | |
| X | In distribution | |
| A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Finapres | Finapres Medical Systems B.V. | 14 |
| Hokanson | D. E. Hokanson, Inc. | 11 |
| EV1000 | Edwards Lifesciences Technology Sarl | 9 |
| Valhalla Scientific, Inc | Valhalla Scientific, Inc. | 9 |
| ReDS System | Sensible Medical Innovations Ltd. | 7 |
| ReDS Pro System | Sensible Medical Innovations Ltd. | 6 |
| Avivo™ | Medtronic, Inc. | 3 |
| ICG cable | Cnsystems Medizintechnik GmbH | 3 |
| PhysioFlow | Manatec | 3 |
| uCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | 3 |
| ReDS Wearable System | Sensible Medical Innovations Ltd. | 3 |
| Flying-V – finger cuff (medium) | Cnsystems Medizintechnik GmbH | 3 |
Showing 12 of 66. All products under Plethysmograph, Impedance
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K014063 | 2002-02-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Partners In Medicine Llc | 510(k) number | 2015-12-01 | Class II | Mixed-up of materials/components | Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects – mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic bl | 28 worldwide 2 monitors distributed in the U.S. | 2017-02-17 |
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.