FDA 510(k) Application Details - K180366

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K180366
Device Name	Calculator, Drug Dose
Applicant	Al Pacheco and Associates 2643 Galicia Way Carlsbad, CA 92009 US Other 510(k) Applications for this Company
Contact	Al Pacheco 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	02/12/2018
Decision Date	09/20/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review