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FDA 510(k) Application Details - K200941
Device Classification Name
More FDA Info for this Device
510(K) Number
K200941
Device Name
Rapid LVO
Applicant
iSchemaView Inc.
433 Park Point Drive, Suite 220
Golden, CO 80401 US
Other 510(k) Applications for this Company
Contact
Jim Rosa
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/08/2020
Decision Date
07/09/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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