The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Heidelberg Engineering Slitlamp-oct (sl-oct).
| Device ID | K052935 |
| 510k Number | K052935 |
| Device Name: | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | HEIDELBERG ENGINEERING GERHART-HAUPTMANN-STRASSE 30 Dossenheim, DE 69221 |
| Contact | Gerhard Zinser |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-19 |
| Decision Date | 2006-01-13 |
| Summary: | summary |