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510(k) K140251

UNIVERSAL DIGITAL INTERFACE 2, UDI 2 by Meridian Medical Systems, LLC — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2014
Date Received
January 31, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Meridian Medical Systems, LLC

  • K162687 — Paragon 2 (October 21, 2016)
  • K143232 — Universal Digital Interface 2W, UDI 2W (January 30, 2015)
  • K112527 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (May 22, 2012)
  • K111305 — UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W (January 31, 2012)
  • K103599 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (April 27, 2011)
  • K945984 — MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS (December 27, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)

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