LCD Monitor

FDA 510(k) K140956 · Nordicneurolab

Substantially Equivalent

510(k) numberK140956

Submission

Device name
LCD Monitor
Applicant
Nordicneurolab
Bergen, Hordaland, NO
Received
April 14, 2014
Decision date
August 7, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LNH – System, Nuclear Magnetic Resonance Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

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Questions and answers

When was LCD Monitor cleared by the FDA?

LCD Monitor (K140956) received a 510(k) decision of Substantially Equivalent on August 7, 2014, 115 days after the submission was received.

What is the product code of K140956?

The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.