FDA 510(k) Application Details - K240610

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K240610
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	DAMAE Medical 14 Rue Sthrau Paris 75013 FR Other 510(k) Applications for this Company
Contact	David Siret Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	NQQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2024
Decision Date	07/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review