510(k) K130849
K130849 is an FDA 510(k) premarket notification submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN for the device "INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450". The FDA issued a decision of Substantially Equivalent on June 14, 2013. 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
- June 14, 2013
- Date Received
- March 26, 2013
- 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