SphygmoCor
Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power…
Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power cord/adapter, BP cuffs, and others). CONFIGURATIONS ENCOMPASSED BY THE XCEL VERSION/MODEL: • XCEL-PWA Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • XCEL-PWV Configuration: [SphygmoCor software configured for pulse wave velocity (PWV) only]. • XCEL-PWA+PWV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)].
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (1), Shanghai (1). 4 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 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | Guangdong | Specification developer | 7 |
Record
| Listed by | Atcor Medical Pty Ltd, Australia |
|---|---|
| FDA product code | DSK |
| Device type | Computer, Blood-Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1110 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K122129 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XCEL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Computer, Blood-Pressure | St. Jude Medical | 39 |
| Zurich Medical Accessory Cable | Zurich Medical Inc | 33 |
| M Series CCT | Zoll Medical Corporation | 33 |
| PressureWire™ | St. Jude Medical | 11 |
| Propaq M | Zoll Medical Corporation | 10 |
| Safedraw™ | Argon Critical Care Systems Singapore PTE. Ltd. | 8 |
| Computer, Blood-Pressure | Physio-Control, Inc. | 7 |
| SJM™ | St. Jude Medical | 4 |
| Quantien™ | St. Jude Medical | 4 |
| SureSigns VSi | Philips Medical Systems Hsg | 3 |
| Avvigo™ Guidance System | Boston Scientific Corporation | 2 |
| SureSigns VS2+ | Philips Medical Systems Hsg | 2 |
Showing 12 of 36. All products under Computer, Blood-Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080670 | 2008-04-23 |
| K070795 | 2007-08-31 |
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.