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FDA 510(k) Application Details - K230691
Device Classification Name
System, Imaging, Optical Coherence Tomography (Oct)
More FDA Info for this Device
510(K) Number
K230691
Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Applicant
SpectraWAVE Inc
12 Oak Park Drive
Bedford, MA 01730 US
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Contact
Farzad Parsaie
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
NQQ
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More FDA Info for this Product Code
Date Received
03/13/2023
Decision Date
06/07/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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