The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Pentacam Axl.
| Device ID | K152311 |
| 510k Number | K152311 |
| Device Name: | Pentacam AXL |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STRASE 29 Wetzla, DE 35582 |
| Contact | Eckhard Loh |
| Correspondent | Randy Prebula HOGAN LOVELLS US LLP 555 THIRTEENTH STREET NW Washington, DC 20016 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-14 |
| Decision Date | 2016-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049584012333 | K152311 | 000 |