Hokanson
DOPPLER AND PLETHYSMOGRAPH SYSTEM - The line-powered instrument contains a direction-sensing continuous wave Doppler, a photo plethysmograph, and a pneumo plethysmograph. Several types of…
DOPPLER AND PLETHYSMOGRAPH SYSTEM – The line-powered instrument contains a direction-sensing continuous wave Doppler, a photo plethysmograph, and a pneumo plethysmograph. Several types of diagnostic tests can be performed allowing the user to choose the most appropriate one for the particular study of interest. A built-in two speed chart recorder can record the waveform from the selected instrument mode. A digital output is included so waveforms can also be captured in computer software.
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 | D. E. Hokanson, Inc., United States |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K896034 |
| Record published | 2016-09-16 |
| Record revised | 2023-11-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2020-02-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PPG sensor 4 Pin | In distribution | |
| MD35/CW1A/TL400 Doppler Barrel | In distribution | |
| PPG sensor 4 Pin – EC6 | In distribution | |
| MD35 | In distribution | |
| MD35 Doppler Handle | In distribution | |
| MD35 | In distribution | |
| MD35 | Withdrawn | |
| PPG sensor | Withdrawn | |
| MD35 Doppler Barrel | Withdrawn | |
| MD35 Doppler Barrel | Withdrawn | |
| MD35 Doppler Probe | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Finapres | Finapres Medical Systems B.V. | 14 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K896034 | 1990-01-18 |
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.