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FDA 510(k) Application Details - DEN230015
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN230015
Device Name
Osteoboost Belt
Applicant
Bone Health Technologies, Inc
370 Convention Way
Suite 218
Redwood City, CA 94063 US
Other 510(k) Applications for this Company
Contact
Laura Yecies
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QZO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/17/2023
Decision Date
01/12/2024
Decision
DENG -
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
FDA Source Information for DEN230015
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