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510(k) K142244

CLEO PATIENT MONITOR by Infinium Medical — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2015
Date Received
August 13, 2014
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

  • 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)
  • K101052 — OMNI III PATIENT MONITOR (August 11, 2010)

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  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
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