FDA 510(k) Application Details - K181327

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K181327
Device Name	Calculator, Drug Dose
Applicant	Companion Medical, Inc. 16486 Bernardo Center Drive, # 300 San Diego, CA 92128 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	05/18/2018
Decision Date	07/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review