The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Heidelberg Retina Tomograph Ii / Rostock Cornea Module (hrt Ii / Rcm).
| Device ID | K042742 |
| 510k Number | K042742 |
| Device Name: | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | HEIDELBERG ENGINEERING GERHART-HAUPTMANN-STRASSE 30 Dossenheim, DE 69221 |
| Contact | Gerhard Zinser |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2004-10-13 |
| Summary: | summary |