510(k) K213490
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P by
Ge Medical Systems Information Technologies, Inc.
— Product Code MHX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2022
- Date Received
- November 1, 2021
- 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