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510(k) K131854

CEROX by Or-Nim Medical , Ltd. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2013
Date Received
June 21, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Or-Nim Medical , Ltd.

  • K150268 — CerOX (November 6, 2015)
  • K100875 — CEROX, MODEL 321OF (January 25, 2011)
  • K093923 — CEROX MODEL 3210 (January 19, 2010)
  • K073407 — PACIFICA (February 28, 2008)

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