The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Spectralis Hra+oct And Variants With Oct Angiography Module.
Device ID | K181594 |
510k Number | K181594 |
Device Name: | Spectralis HRA+OCT And Variants With OCT Angiography Module |
Classification | Tomography, Optical Coherence |
Applicant | Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 Heidelberg, DE 69115 |
Contact | Christoph Schoess |
Correspondent | Lena Sattler Orasi Consulting, LLC. 1655 Forest Drive Medina, OH 44256 |
Product Code | OBO |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-18 |
Decision Date | 2018-09-13 |
Summary: | summary |