ECVUE Mapping System

FDA 510(k) K150990 · Cardioinsight Technologies, Inc.

Substantially Equivalent

510(k) numberK150990

Submission

Device name
ECVUE Mapping System
Applicant
Cardioinsight Technologies, Inc.
Cleveland, OH, US
Received
April 15, 2015
Decision date
July 2, 2015
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQK – Computer, Diagnostic, Programmable
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1425
Specialty
Cardiovascular

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More from iRhythm Technologies, Inc.

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K162440CardioInsight Cardiac Mapping SystemDQK · Special 11/04/2016SE
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Questions and answers

When was ECVUE Mapping System cleared by the FDA?

ECVUE Mapping System (K150990) received a 510(k) decision of Substantially Equivalent on July 2, 2015, 78 days after the submission was received.

What is the product code of K150990?

The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.