Medchannel HTS System

FDA 510(k) K061831 · Medchannel, LLC

Substantially Equivalent

510(k) numberK061831

Submission

Device name
Medchannel HTS System
Applicant
Medchannel, LLC
Boston, MA, US
Received
June 28, 2006
Decision date
August 7, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1550
Specialty
Radiology

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Questions and answers

When was Medchannel HTS System cleared by the FDA?

Medchannel HTS System (K061831) received a 510(k) decision of Substantially Equivalent on August 7, 2006, 40 days after the submission was received.

What is the product code of K061831?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.