The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Spectralis Hra + Oct And Variants (e.g.s Below), Spectralis Fa+oct, Spectralis Icga+oct, Spectralis Oct Blue Peak, Spectralis Oct Ith Multicolor.
| Device ID | K152205 |
| 510k Number | K152205 |
| Device Name: | Spectralis HRA + OCT And Variants (e.g.s Below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT Ith Multicolor |
| Classification | Tomography, Optical Coherence |
| Applicant | Heidelberg Engineering GmbH Heidelberg, DE 69121 |
| Contact | Gerhard Zinser |
| Correspondent | Diane Horwitz Mandell Horwitz Consultants LLC 2995 Steven Martin Dr. Fairfax, VA 22031 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-06 |
| Decision Date | 2016-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059237000358 | K152205 | 000 |
| 04059237000341 | K152205 | 000 |
| 04059237000310 | K152205 | 000 |
| 04059237000303 | K152205 | 000 |
| 04059237000259 | K152205 | 000 |
| 04059237000150 | K152205 | 000 |
| 04059237000136 | K152205 | 000 |
| 04059237000105 | K152205 | 000 |
| 04059237000068 | K152205 | 000 |