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510(k) K132229

OMNI PATENT MONITORS by Infinium Medical — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2014
Date Received
July 18, 2013
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)
  • K112329 — OMNI PATIENT MONITOR (September 8, 2011)
  • K103737 — OMNI II PATIENT MONITOR (June 2, 2011)
  • K103268 — OMNI EXPRESS (November 23, 2010)
  • K101052 — OMNI III PATIENT MONITOR (August 11, 2010)

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