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.
| Device ID | K121993 |
| 510k Number | K121993 |
| Device Name: | SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT |
| Classification | Tomography, Optical Coherence |
| Applicant | HEIDELBERG ENGINEERING GMBH 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Contact | Diane Horwitz, Ph.d. |
| Correspondent | Diane Horwitz, Ph.d. HEIDELBERG ENGINEERING GMBH 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 | 2012-07-06 |
| Decision Date | 2012-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059237000297 | K121993 | 000 |
| 04059237000099 | K121993 | 000 |
| 04059237000082 | K121993 | 000 |