The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Spectralis Hra + Oct And Variants.
Device ID | K173648 |
510k Number | K173648 |
Device Name: | Spectralis HRA + OCT And Variants |
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 Dr. 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 | 2017-11-27 |
Decision Date | 2018-08-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04059237000549 | K173648 | 000 |
04059237000525 | K173648 | 000 |
04059237000501 | K173648 | 000 |