FDA 510(k) Application Details - K242066

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K242066
Device Name	Calculator, Drug Dose
Applicant	Amalgam Rx, Inc 1007 N. Orange St., Ste.400 Wilmington, DE 19801 US Other 510(k) Applications for this Company
Contact	Miller Andy 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	07/15/2024
Decision Date	08/21/2024
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