The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Spectralis Hra+oct, Spectralis Fa_oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis Fa.
| Device ID | K101223 |
| 510k Number | K101223 |
| Device Name: | SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA |
| Classification | Tomography, Optical Coherence |
| Applicant | HEIDELBERG ENGINEERING 1220 NINETEENTH ST, NW SUITE 300 Washington, DC 20036 |
| Contact | Diane Mandell-horwitz |
| Correspondent | Diane Mandell-horwitz HEIDELBERG ENGINEERING 1220 NINETEENTH ST, NW SUITE 300 Washington, DC 20036 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-03 |
| Decision Date | 2010-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059237000280 | K101223 | 000 |
| 04059237000075 | K101223 | 000 |
| 04059237000051 | K101223 | 000 |
| 04059237000044 | K101223 | 000 |
| 04059237000037 | K101223 | 000 |
| 04059237000020 | K101223 | 000 |
| 04059237000013 | K101223 | 000 |