Clearance Summary
Bloomlife MFM-Pro received FDA 510(k) clearance under submission number K222327, sponsored by Bloom Technologies NV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2023-02-13.
- Submission: K222327
- Applicant / Sponsor: Bloom Technologies NV
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2023-02-13
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.