Who else makes this device?

Name: 8.0 MHz Superficial Vascular Probe
Brand: 8.0 MHz Superficial Vascular Probe

Obstetrics & Gynecology › MonitoringMonitor, Blood-Flow, Ultrasonic

8.0 MHz Superficial Vascular Probe

Catalogue number TSP-8, listed by Coopersurgical, Inc., United States, under Monitor, Blood-Flow, Ultrasonic. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

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 8.0 MHz Superficial Vascular Probe
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	2016-03-31
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 8.0 MHz Superficial Vascular Probe
Catalogue number	Size	Status
TSP-8		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
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
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.