FDA 510(k) Application Details - K200516

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K200516
Device Name	Tomography, Optical Coherence
Applicant	OptoMedical Technologies GmbH Maria-Goeppert-Strasse 9 Luebeck 23562 DE Other 510(k) Applications for this Company
Contact	Julia Behrens 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	03/02/2020
Decision Date	09/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review