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510(k) K103737

OMNI II PATIENT MONITOR by Infinium Medical — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2011
Date Received
December 22, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Infinium Medical

  • K142244 — CLEO PATIENT MONITOR (February 6, 2015)
  • K132229 — OMNI PATENT MONITORS (February 21, 2014)
  • K112329 — OMNI PATIENT MONITOR (September 8, 2011)
  • K103268 — OMNI EXPRESS (November 23, 2010)
  • K101052 — OMNI III PATIENT MONITOR (August 11, 2010)

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