FDA 510(k) Application Details - K190487

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K190487
Device Name	Calculator, Drug Dose
Applicant	Companion Medical, Inc. 11011 Via Frontera, Suite D San Diego, CA 92127 US Other 510(k) Applications for this Company
Contact	Jasper Benke 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	02/28/2019
Decision Date	02/18/2020
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