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FDA 510(k) Application Details - K201337
Device Classification Name
Calculator, Drug Dose
More FDA Info for this Device
510(K) Number
K201337
Device Name
Calculator, Drug Dose
Applicant
Companion Medical, Inc.
12230 World Trade Drive, Suite 100
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
05/20/2020
Decision Date
06/18/2020
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
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