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510(k) K162687

Paragon 2 by Meridian Medical Systems, LLC — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2016
Date Received
September 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Meridian Medical Systems, LLC

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  • 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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