FDA 510(k) Application Details - K242775

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K242775
Device Name	Calculator, Drug Dose
Applicant	Medtronic MiniMed 18000 Devonshire Street Northridge, CA 92325 US Other 510(k) Applications for this Company
Contact	Ty Cowart Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	NDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2024
Decision Date	11/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review