510(k) K172226
K172226 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "MX40 Release B.07". The FDA issued a decision of Substantially Equivalent on November 9, 2017. 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 has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2017
- Date Received
- July 25, 2017
- 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