510(k) K103737
K103737 is an FDA 510(k) premarket notification submitted by Infinium Medical for the device "OMNI II PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on Jun 2, 2011. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Infinium Medical has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 2011
- Date Received
- Dec 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
- 510(k)