BiDop 7
BiDop 7 is a handheld Doppler device for detecting arterial and venous blood flow in the limbs and fetal heart sounds. It displays bidirectional velocity waveforms and numerical…
BiDop 7 is a handheld Doppler device for detecting arterial and venous blood flow in the limbs and fetal heart sounds. It displays bidirectional velocity waveforms and numerical information, including fetal heart rate when used for that application. It also supports ankle brachial and toe brachial pressure studies.
A probe transmits ultrasound and receives echoes from moving blood. The device processes the resulting frequency shift into audible sounds and displayed blood flow waveforms. Different Doppler probes provide operating frequencies of 2, 5, 8 or 10 MHz.
Listed Item
Hand held Doppler
Additional Vascular Measurements
A photoplethysmography probe uses infrared light reflected from blood in superficial vessels for toe pressure, waveform and venous reflux studies. The system helps the examiner obtain segmental systolic pressure information.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
| Dongguan Mars Medical Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Koven Technology, Inc., United States |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K201114 |
| Record published | 2021-01-20 |
| Record revised | 2023-11-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BiDop 7 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transonic | Transonic Systems, Inc. | 627 |
| SonoTT Vascular Probe | Em-Tec GmbH | 12 |
| BiDop 7 probe | Koven Technology, Inc. | 8 |
| Medistim MiraQ Cardiac System | Medistim ASA | 6 |
| Medistim MiraQ Vascular System | Medistim ASA | 6 |
| FlowMet™ | Medtronic, Inc. | 4 |
| GEM Flow Coupler | Synovis Micro Companies Alliance | 4 |
| CooperSurgical® | Coopersurgical, Inc. | 4 |
| Medistim System Activation Card | Medistim ASA | 3 |
| 811-BL 24V Foreign & Domestic | Parks Medical Electronics, Inc. | 3 |
| Medistim MiraQ Ultimate System | Medistim ASA | 3 |
| Dopplex | Huntleigh Healthcare Ltd. | 3 |
Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201114 | 2021-01-05 |
| K050601 | 2005-04-15 |
| K031931 | 2004-02-13 |
| K010452 | 2002-02-12 |
| K982986 | 1998-11-24 |
| K954397 | 1996-03-29 |
| K942613 | 1994-12-23 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-03-04 | Class II | Labeling Change Control | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | 34 |
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.