CardioSTAT
CardioSTAT Installation Kit - ECG Recorder 2D Test.
4manufacturers in China registered for this device type
6catalogue 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 | Icentia Inc, Canada |
|---|---|
| FDA product code | DSH |
| Device type | Recorder, Magnetic Tape, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K223049 |
| Record published | 2024-03-26 |
| Record revised | 2025-02-21 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date, manufacturing date, serial number |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-006 | In distribution | |
| 10-006 | In distribution | |
| 10-006 | In distribution | |
| 10-006 | In distribution | |
| 10-006 | In distribution | |
| 10-006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 33 |
| Matrix Wearable | Global Instrumentation, LLC | 12 |
| Holter ECG and ABP System | Edan Instruments, Inc. | 5 |
| Epatch Sensor | Braemar Manufacturing, LLC | 5 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 4 |
| Nuubo System | Smart Solutions Technologies SL | 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 |
|---|---|
| K223049 | 2023-03-22 |
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.