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FDA 510(k) Application Details - K241719
Device Classification Name
More FDA Info for this Device
510(K) Number
K241719
Device Name
NeuroICH
Applicant
Neurocareai Inc.
8992 Preston Rd Ste 110-255
Frisco, TX 75034 US
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Contact
Junaid Saddiq Kalia
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Regulation Number
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Classification Product Code
QAS
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More FDA Info for this Product Code
Date Received
06/14/2024
Decision Date
11/07/2024
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
FDA Source Information for K241719
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