Bloomlife MFM-Pro— 510(k) K222327

Substantially Equivalent

Bloom Technologies NV

FDA 510(k) clearance K222327 for Bloomlife MFM-Pro, Substantially Equivalent on 2023-02-13. Applicant: Bloom Technologies NV.

Clearance details

Applicant: Bloom Technologies NV
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2022-08-02
Decision date: 2023-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Genk, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.