The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Pentacam Scheimpflug Camera.
| Device ID | K030719 |
| 510k Number | K030719 |
| Device Name: | PENTACAM SCHEIMPFLUG CAMERA |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | OCULUS OPTIKGERATE GMBH 18902 NE 150TH ST. Woodinville, WA 98072 |
| Contact | Tom Weatherby |
| Correspondent | Tom Weatherby OCULUS OPTIKGERATE GMBH 18902 NE 150TH ST. Woodinville, WA 98072 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-07 |
| Decision Date | 2003-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049584000026 | K030719 | 000 |
| 04049584000019 | K030719 | 000 |