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FDA 510(k) Application Details - K200741
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K200741
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
Outset Medical, Inc.
1830 Bering Drive
San Jose, CA 95112 US
Other 510(k) Applications for this Company
Contact
Jennifer Mascioli-Tudor
Other 510(k) Applications for this Contact
Regulation Number
876.5860
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Classification Product Code
KDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/23/2020
Decision Date
03/31/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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