510(k) K190008
K190008 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Carescape One". The FDA issued a decision of Substantially Equivalent on Dec 20, 2019. 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 Healthcare has 168 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2019
- Date Received
- Jan 2, 2019
- 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
- 510(k)