FDA 510(k) Applications Submitted by Bioptigen, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K120057 01/09/2012 ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) BIOPTIGEN, INC.
K162783 10/03/2016 EnFocus 2300, EnFocus 4400 Bioptigen, Inc.
K063343 11/06/2006 BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM BIOPTIGEN, INC.
K150722 03/20/2015 EnFocus 2300, EnFocus 4400 BIOPTIGEN, INC.


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