Device Classification Name calculator, drug dose
510(k) Number K161865
Device Name iSage Rx (iSage Rx Basal Insulin Titration)
Applicant
iSag Rx, Inc.
206 ALAPOCAS DR
wilmington,  DE  19803
Applicant Contact ryan sysko
Correspondent
iSag Rx, Inc.
206 ALAPOCAS DR
wilmington,  DE  19803
Correspondent Contact ryan sysko
Regulation Number868.1890
Classification Product Code
NDC  
Date Received07/07/2016
Decision Date 03/07/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No