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FDA 510(k) Application Details - K221319
Device Classification Name
More FDA Info for this Device
510(K) Number
K221319
Device Name
BD AlarisÖ Pump Epidural Infusion Set
Applicant
CareFusion
10020 Pacific Mesa Blvd
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Paulina Davis
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PWH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2022
Decision Date
07/21/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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