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FDA 510(k) Application Details - K231485
Device Classification Name
More FDA Info for this Device
510(K) Number
K231485
Device Name
iLet« ACE Pump
Applicant
Beta Bionics, Inc.
300 Baker Ave Ste 301
Concord, MA 01742-2131 US
Other 510(k) Applications for this Company
Contact
Liz Cooper
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QFG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2023
Decision Date
06/21/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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