510(k) K253654
K253654 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Böblingen GmbH for the device "IntelliVue Measurement Rack 6000 (867317)". The FDA issued a decision of Substantially Equivalent on March 30, 2026. 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 Böblingen GmbH has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2026
- Date Received
- November 20, 2025
- Clearance Type
- Traditional
- 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