Summit Doppler

LifeDop 250 Professional Obstetrical and Vascular Combination with 3.0 MHz and 8.0 MHz Probes

Registry build 21.09.26
1manufacturer
34catalogue 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 Summit 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 2016-07-21
Record revised 2024-02-28 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Hydrogen Peroxide
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries serial number

Catalogue Numbers

Catalogue numbers for Summit Doppler
Catalogue number Size Status
L250R-SD5 In distribution
SD5 In distribution
L250AR-SD4 In distribution
L250AR-STN In distribution
L250R-SD4 In distribution
L150-STN In distribution
L150R-STN In distribution
L150R-SD4 In distribution
C250CV In distribution
L150A-SD8 In distribution
C250CC In distribution
L250-SDE In distribution
L250R-STN In distribution
L250R-SDE In distribution
L150R-SD5 In distribution
L150-SD8 In distribution
L250-SD8 In distribution
L250-SD4 In distribution
L150A-SD4 In distribution
L150R-SD8 In distribution
L250-SD5 In distribution
L250AR-SDE In distribution
L250-STN In distribution
L250AR-SD5 In distribution
L250R-SD8 In distribution
L150A-SDW In distribution
L150-SD5 In distribution
STN In distribution
L250AR-SD8 In distribution
L150A-SD5 In distribution
SD4 In distribution
L150-SD4 In distribution
SD8 In distribution
SDE In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MediChoice Coopersurgical, Inc. 20
ClearTone Doppler Coopersurgical, Inc. 10
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