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FDA 510(k), K222327, Bloomlife MFM-Pro
FDA 510(k), K222327, Bloomlife MFM-Pro
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$149.00 USD
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510(K) Number: K222327
Device Name: Bloomlife MFM-Pro
Manufacturer: Roberto Cunha
Device Classification Name: System, Monitoring, Perinatal
Regulation Number: HGM
Classification Product Code: 08/02/2022
Date Received: 02/13/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Bloomlife MFM-Pro
Manufacturer: Roberto Cunha
Device Classification Name: System, Monitoring, Perinatal
Regulation Number: HGM
Classification Product Code: 08/02/2022
Date Received: 02/13/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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