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 |