Monitor, Blood-Flow, Ultrasonic
8 catalogue numbers from 5MHz, listed by Edan Instruments, Inc., China, under Monitor, Blood-Flow, Ultrasonic. 1 manufacturer in China is registered for this product code.
1manufacturer
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Edan Instruments, Inc., China |
|---|---|
| FDA product code | HEP |
| Device type | Monitor, Blood-Flow, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2660 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K140579 |
| Record published | 2016-09-01 |
| Record revised | 2023-11-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5MHz | In distribution | |
| 4.0MHz | In distribution | |
| 8.0MHz | In distribution | |
| 5.0MHz | In distribution | |
| 2.0MHz | In distribution | |
| 3.0MHz | In distribution | |
| 4MHz | In distribution | |
| 8MHz | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Summit Doppler | Coopersurgical, Inc. | 34 |
| MediChoice | Coopersurgical, Inc. | 20 |
| ClearTone Doppler | Coopersurgical, Inc. | 10 |
| Natus Neurology | Natus Neurology Incorporated | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 6 |
| E-ST | Avante | 5 |
| Tria II Display Doppler | Coopersurgical, Inc. | 3 |
| Tria II Doppler | Coopersurgical, Inc. | 3 |
| Advanced Pocket Doppler | Advanced Instrumentations, Inc. | 2 |
| Medi Choice | Coopersurgical, Inc. | 1 |
| 8.0 MHz Superficial Vascular Probe | Coopersurgical, Inc. | 1 |
| Mediblu | Mediblu Medical, LLC | 1 |
Showing 12 of 16. All products under Monitor, Blood-Flow, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101960 | 2010-08-10 |
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.