FDA 510(k) Application Details - K221924

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K221924
Device Name	Calculator, Drug Dose
Applicant	GNC Holdings, LLC 75 Hopper Pl Pittsburgh, PA 15222 US Other 510(k) Applications for this Company
Contact	YongKai Wong 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	07/01/2022
Decision Date	03/15/2023
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