FDA 510(k) Application Details - K201619

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K201619
Device Name	Calculator, Drug Dose
Applicant	Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd, Suite N Charlotte, NC 28217 US Other 510(k) Applications for this Company
Contact	Ann Marie Gaitan 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	06/15/2020
Decision Date	08/07/2020
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