Who else makes this device?

Name: Dopplex
Brand: Dopplex

Dopplex · Transducer, Ultrasonic, Obstetric → Obstetrics & Gynecology

2manufacturers in China registered for this device type

3catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code HGL
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Orantech Inc.	Shenzhen	Guangdong	Contract manufacturer	40

Record

Regulatory record for Dopplex
Listed by	Huntleigh Healthcare Ltd., United Kingdom
FDA product code	HGL
Device type	Transducer, Ultrasonic, Obstetric
Device class	Class 2
Regulation	21 CFR 884.2960
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K183574
Record published	2020-02-17
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 5 to 40 °C; Storage environment temperature -25 to 5 °C; Handling environment humidity 15 to 93 % RH; Storage environment humidity up to 93 % RH; Handling environment atmospheric pressure 700 to 1060 millibar; Storage environment atmospheric pressure 700 to 1060 millibar

Catalogue Numbers

Catalogue numbers for Dopplex
Catalogue number	Size	Status
OP2XS-USA		In distribution
SONICAIDONE		In distribution
OP3XS-USA		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ultrasound Transducer	Edan Instruments, Inc.	4
US Transducer	Edan Instruments, Inc.	3
Fetal & Maternal Module	Edan Instruments, Inc.	2
Toco Transducer	Edan Instruments, Inc.	2
Fetal monitor	Edan Instruments, Inc.	2
AIV	American IV Products, Inc.	1
2.20MHZ OB Probe 641-A	Parks Medical Electronics, Inc.	1
2.75 MHZ OB Probe	Parks Medical Electronics, Inc.	1
Transducer, Ultrasonic, Obstetric	Edan Instruments, Inc.	1
2.00MHZ OB Probe 641	Parks Medical Electronics, Inc.	1
2.10MHZ OB Probe 641	Parks Medical Electronics, Inc.	1
2.10MHZ OB Probe 641-A	Parks Medical Electronics, Inc.	1

Showing 12 of 27. All products under Transducer, Ultrasonic, Obstetric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K924516	1993-06-28

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P800016	1986-01-08	TENNANT(TM) & KELMAN(TM) TYPE II	Bausch & Lomb Incorporated

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.

Dopplex