Finapres
BeatScope Easy CD + User's Guide
5manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Finapres Medical Systems B.V., Netherlands |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Manufacturer |
| 510(k) | K023723 |
| Record published | 2016-09-24 |
| Record revised | 2018-12-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECG Module | In distribution | |
| Finometer Model-1 115V | In distribution | |
| Finometer Model-1 230V | In distribution | |
| FM-M1 Upper arm cuff | In distribution | |
| PP Height Correction Unit | In distribution | |
| BeatScope Easy | In distribution | |
| ECG Module | In distribution | |
| Finger cuff size Medium | In distribution | |
| BeatScope 1.1a | In distribution | |
| Finger cuff size Small | In distribution | |
| Finger cuff size Large | In distribution | |
| FM Frontend Unit | In distribution | |
| FM Height Correction Unit | In distribution | |
| Finometer Model-1 Frontend Unit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| ECG 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
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 |
|---|---|---|---|---|---|---|---|
| Finapres Medical Systems B.V. | 510(k) number | 2012-07-06 | Class II | Process control | Battery may become hot and leak | 3 units US | 2012-09-12 |
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.