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510(k) K103268

OMNI EXPRESS by Infinium Medical — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2010
Date Received
November 4, 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

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  • K103737 — OMNI II PATIENT MONITOR (June 2, 2011)
  • K101052 — OMNI III PATIENT MONITOR (August 11, 2010)

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