The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Spectralis Anterior Segment Module (spectralis Asm).
| Device ID | K113129 |
| 510k Number | K113129 |
| Device Name: | SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) |
| Classification | Tomography, Optical Coherence |
| Applicant | HEIDELBERG ENGINEERING GMBH TIERGARTENSTRASSE 15 Heidelberg, DE 69121 |
| Contact | Gerhard Zinser |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2011-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059237000112 | K113129 | 000 |