510(k) K082583
K082583 is an FDA 510(k) premarket notification submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN for the device "INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5". The FDA issued a decision of Substantially Equivalent on February 25, 2009. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Philips Medizinsysteme Boeblingen GmbH, Cardiac AN has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2009
- Date Received
- September 8, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type