510(k) K042845
K042845 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boblingen GmbH for the device "THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS". The FDA issued a decision of Substantially Equivalent on November 12, 2004. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Philips Medizin Systeme Boblingen GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2004
- Date Received
- October 15, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type