FDA 510(k) Application Details - K230734

Device Classification Name	More FDA Info for this Device
510(K) Number	K230734
Device Name	Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
Applicant	Precision Healing LLC 1200 Summit Ave Ste 414 Fort Worth, TX 76102 US Other 510(k) Applications for this Company
Contact	Robert Brik Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2023
Decision Date	12/05/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review