510(k) K062283
K062283 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America, Inc. for the device "THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS". The FDA issued a decision of Substantially Equivalent on September 20, 2006. 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 Medical Systems North America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2006
- Date Received
- August 7, 2006
- 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