510(k) K111905
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 by
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
— Product Code DXJ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2011
- Date Received
- July 5, 2011
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Cathode-Ray Tube, Medical
- Device Class
- Class II
- Regulation Number
- 870.2450
- Review Panel
- CV
- Submission Type