Cardio-View

FDA 510(k) K083321 · Curlview Igt, LLC

Substantially Equivalent

510(k) numberK083321

Submission

Device name
Cardio-View
Applicant
Curlview Igt, LLC
Newton, MA, US
Received
November 11, 2008
Decision date
November 26, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
DXJ – Display, Cathode-Ray Tube, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2450
Specialty
Cardiovascular

Other 510(k)s with product code DXJ

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K212003ESSENZ Patient MonitorDXJ · Special Livanova Deutschland, GmbH11/10/2021SE
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K201162Essence 55SP Large Monitor SystemDXJ · Traditional Shenyang Torch-Bigtide Digital Technology Co.…08/27/2020SE
K173107Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional Vios Medical, Inc.07/26/2018SE
K180534Philips IntelliVue GuardianSoftwareDXJ · Traditional Philips Medizin Systeme Boeblingen GmbH07/16/2018SE
K173381Nexxis ORDXJ · Special Barco N.V.02/22/2018SE
K172969Essence 55S Large Monitor SystemDXJ · Traditional Shenyang Torch-Bigtide Digital Technology Co.…01/26/2018SE
K170460Sorin ConnectDXJ · Special Sorin Group Deutschland GmbH06/08/2017SE
K170537Nexxis OR, NexxisDXJ · Special Barco N.V.04/21/2017SE
K161880NIVR58-T kitDXJ · Special Barco N.V.03/14/2017SE

Questions and answers

When was Cardio-View cleared by the FDA?

Cardio-View (K083321) received a 510(k) decision of Substantially Equivalent on November 26, 2008, 15 days after the submission was received.

What is the product code of K083321?

The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.