FDA 510(k) Application Details - K241719

Device Classification Name

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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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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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