The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Spectralis Hra+oct And Variants With High Magnification Module.
Device ID | K182569 |
510k Number | K182569 |
Device Name: | Spectralis HRA+OCT And Variants With High Magnification Module |
Classification | Tomography, Optical Coherence |
Applicant | Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 Heidelberg, DE 69115 |
Contact | Arianna Schoess |
Correspondent | Lena Sattler Orasi Consulting, LLC. 1655 Forest Dr. Medina, OH 44256 |
Product Code | OBO |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-18 |
Decision Date | 2018-10-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04059237000211 | K182569 | 000 |
04059237000594 | K182569 | 000 |
04059237000570 | K182569 | 000 |