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510(k) K150268

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2015
Date Received
February 4, 2015
Clearance Type
Traditional
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.

  • K131854 — CEROX (September 13, 2013)
  • K100875 — CEROX, MODEL 321OF (January 25, 2011)
  • K093923 — CEROX MODEL 3210 (January 19, 2010)
  • K073407 — PACIFICA (February 28, 2008)

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