The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Spectralis Hra + Oct And Variants, Spectralis Fa+oct, Spectralis Icga+oct, Spectralis Oct Blue Peak, Spectralis Oct With Multicolor.
| Device ID | K172649 |
| 510k Number | K172649 |
| Device Name: | Spectralis HRA + OCT And Variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT With Multicolor |
| Classification | Tomography, Optical Coherence |
| Applicant | Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 Heidelberg, DE 69115 |
| Contact | Gerhard Zinser |
| 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 | 2017-09-05 |
| Decision Date | 2017-11-01 |
| Summary: | summary |