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FDA 510(k) Application Details - K183052
Device Classification Name
More FDA Info for this Device
510(K) Number
K183052
Device Name
ID-Cap System
Applicant
etectRx, Inc.
747 SW 2nd Ave Suite 365T, IMB 24
Gainesville, FL 32601 US
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Contact
Susan Baumgartner
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OZW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/02/2018
Decision Date
12/06/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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