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FDA 510(k) Application Details - K163664
Device Classification Name
Calculator, Drug Dose
More FDA Info for this Device
510(K) Number
K163664
Device Name
Calculator, Drug Dose
Applicant
ALR TECHNOLOGIES
7400 BEAUFONT SPRINGS DRIVE, SUITE 300
RICHMOND, VA 23225 US
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Contact
SIDNEY CHAN
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
12/27/2016
Decision Date
09/18/2017
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
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