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 | K192391 |
| 510k Number | K192391 |
| Device Name: | Spectralis HRA+OCT And Variants |
| Classification | Tomography, Optical Coherence |
| Applicant | Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 Heidelberg, DE 69115 |
| Contact | Arianna Schoess Vargas |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2019-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059237000716 | K192391 | 000 |
| 04059237000488 | K192391 | 000 |
| 04059237000464 | K192391 | 000 |