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FDA 510(k) Application Details - K172177
Device Classification Name
Calculator, Drug Dose
More FDA Info for this Device
510(K) Number
K172177
Device Name
Calculator, Drug Dose
Applicant
Voluntis S.A.
22 Quai Gallieni
Suresnes 92150 FR
Other 510(k) Applications for this Company
Contact
Kevin Howard
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
07/19/2017
Decision Date
11/07/2017
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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