FDA 510(k) Application Details - K192391

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K192391
Device Name	Tomography, Optical Coherence
Applicant	Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 Heidelberg 69115 DE Other 510(k) Applications for this Company
Contact	Arianna Schoess Vargas Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	OBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2019
Decision Date	09/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review