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 |