Carnation Ambulatory Monitor
3 catalogue numbers from B1000R1400, listed by Bardy Diagnostics, Inc., United States, under Recorder, Magnetic Tape, Medical. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
3catalogue numbers in this listing
7510(k) clearances naming this product code
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 | Bardy Diagnostics, Inc., United States |
|---|---|
| FDA product code | DSH |
| Device type | Recorder, Magnetic Tape, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K191471 |
| Record published | 2019-12-20 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B1000R1400 | In distribution | |
| B1000R7000 | In distribution | |
| B1000R2000 | 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 |
| 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 |
Showing 12 of 122. All products under Recorder, Magnetic Tape, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233110 | 2023-11-22 |
| K210036 | 2021-02-05 |
| K200870 | 2020-05-01 |
| K192556 | 2019-10-17 |
| K191471 | 2019-08-30 |
| K191000 | 2019-05-16 |
| K143067 | 2014-12-22 |
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.