510(k) K221348
K221348 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Böblingen GmbH for the device "IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)". The FDA issued a decision of Substantially Equivalent on February 3, 2023. 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 Medizin Systeme Böblingen GmbH has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2023
- Date Received
- May 9, 2022
- Clearance Type
- Traditional
- 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