FDA 510(k)

Bloomlife MFM-Pro

K-Number: K222327 · 2023-02-13

Decision Date2023-02-13

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Bloomlife MFM-Pro is the device name listed in this FDA 510(k) record. The listed applicant is Bloom Technologies NV. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K222327. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bloomlife MFM-Pro?

Bloomlife MFM-Pro is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Bloom Technologies NV. The 510(k) number is K222327.

When did Bloomlife MFM-Pro receive FDA 510(k) clearance?

Bloomlife MFM-Pro received FDA 510(k) clearance on 2023-02-13, under 510(k) number K222327.

Who is the listed applicant for Bloomlife MFM-Pro?

The FDA 510(k) record lists Bloom Technologies NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bloomlife MFM-Pro?

The FDA product code for Bloomlife MFM-Pro is HGM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.