MD Vision System

FDA 510(k) K101474 · Perkins Healthcare Technologies

Substantially Equivalent

510(k) numberK101474

Submission

Device name
MD Vision System
Applicant
Perkins Healthcare Technologies
Richardson, TX, US
Received
May 28, 2010
Decision date
July 2, 2010
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

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K170460Sorin ConnectDXJ · Special Sorin Group Deutschland GmbH06/08/2017SE
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Questions and answers

When was MD Vision System cleared by the FDA?

MD Vision System (K101474) received a 510(k) decision of Substantially Equivalent on July 2, 2010, 35 days after the submission was received.

What is the product code of K101474?

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