Viewmate System

FDA 510(k) K071028 · Ep Medsystems

Substantially Equivalent

510(k) numberK071028

Submission

Device name
Viewmate System
Applicant
Ep Medsystems
West Berlin, NJ, US
Received
April 11, 2007
Decision date
May 1, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITN – Splint, Denis Brown
Device class
Class I (low risk)
Regulation
21 CFR 890.3675
Specialty
Physical Medicine

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Questions and answers

When was Viewmate System cleared by the FDA?

Viewmate System (K071028) received a 510(k) decision of Substantially Equivalent on May 1, 2007, 20 days after the submission was received.

What is the product code of K071028?

The FDA product code is ITN – Splint, Denis Brown, a Class I (low risk) device regulated under 21 CFR 890.3675.