510(k) BK190333
- Device
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Applicant
- Terumo BCT, Inc
- 510(k) number
- BK190333
- Product code
- MMH
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2019-12-03
- Date received
- 2019-03-22
- Regulation
- 864.9165
- Classification name
- Blood Establishment Computer Software And Accessories
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Legacy Summary#
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FDA Review#
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