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FDA 510(k) Application Details - K213795
Device Classification Name
Analyzer,Medical Image
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510(K) Number
K213795
Device Name
Analyzer,Medical Image
Applicant
VideaHealth, Inc
19 Kingston St
Boston, MA 02111 US
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Contact
Florian Hillen
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MYN
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More FDA Info for this Product Code
Date Received
12/06/2021
Decision Date
04/21/2022
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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