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510(k) K131272

SIREN EPCR SUITE by Medusa Medical Technologies, Inc. — Product Code DXJ

K131272 is an FDA 510(k) premarket notification submitted by Medusa Medical Technologies, Inc. for the device "SIREN EPCR SUITE". The FDA issued a decision of Substantially Equivalent on January 3, 2014. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2014
Date Received
May 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

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FDA data resources