McKesson
Doppler, Perip/Superfcl 8MHZ
1manufacturer
6catalogue numbers in this listing
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 | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | HEP |
| Device type | Monitor, Blood-Flow, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2660 |
| 510(k) | K024197 |
| Record published | 2016-12-09 |
| Record revised | 2023-11-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1166 | In distribution | |
| 1159 | In distribution | |
| 1158 | In distribution | |
| 1165 | In distribution | |
| 1164 | In distribution | |
| 1160 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Summit Doppler | Coopersurgical, Inc. | 34 |
| MediChoice | Coopersurgical, Inc. | 20 |
| ClearTone Doppler | Coopersurgical, Inc. | 10 |
| Monitor, Blood-Flow, Ultrasonic | Edan Instruments, Inc. | 8 |
| Natus Neurology | Natus Neurology Incorporated | 7 |
| 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
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.