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510(k) K101052

OMNI III PATIENT MONITOR by Infinium Medical — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2010
Date Received
April 15, 2010
Clearance Type
Traditional
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)
  • K103737 — OMNI II PATIENT MONITOR (June 2, 2011)
  • K103268 — OMNI EXPRESS (November 23, 2010)

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