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FDA 510(k) Application Details - K220815
Device Classification Name
More FDA Info for this Device
510(K) Number
K220815
Device Name
BrainInsight
Applicant
Hyperfine, Inc.
351 New Whitfield St
Guilford, CT 06437 US
Other 510(k) Applications for this Company
Contact
Christine Kupchick
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QIH
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More FDA Info for this Product Code
Date Received
03/21/2022
Decision Date
07/19/2022
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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