510(k) K201941
K201941 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "Monitor B125, Monitor B105". The FDA issued a decision of Substantially Equivalent on November 4, 2020. 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. Ge Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2020
- Date Received
- July 13, 2020
- 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