510(k) K222327
K222327 is an FDA 510(k) premarket notification submitted by Bloom Technologies NV for the device "Bloomlife MFM-Pro". The FDA issued a decision of Substantially Equivalent on February 13, 2023. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2023
- Date Received
- August 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Monitoring, Perinatal
- Device Class
- Class II
- Regulation Number
- 884.2740
- Review Panel
- OB
- Submission Type