ClearTone Doppler

Non-Display with 8 MHz Vascular Probe - Rechargeable

Registry build 21.09.26
1manufacturer
10catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code HEP
Manufacturer City Province Registered as Device types
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56

Record

Regulatory record for ClearTone Doppler
Listed by Coopersurgical, Inc., United States
FDA product code HEP
Device type Monitor, Blood-Flow, Ultrasonic
Device class Class 2
Regulation 21 CFR 884.2660
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K024197
Record published 2016-07-20
Record revised 2024-02-28 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for ClearTone Doppler
Catalogue number Size Status
CT150-5 In distribution
CT250-8 In distribution
CTP-8 In distribution
CT150-8 In distribution
CT150R-8 In distribution
CT250R-8 In distribution
CTP-5 In distribution
CT250R-5 In distribution
CT150R-5 In distribution
CT250-5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Summit Doppler Coopersurgical, Inc. 34
MediChoice Coopersurgical, Inc. 20
Monitor, Blood-Flow, Ultrasonic Edan Instruments, Inc. 8
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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer