510(k) K030719
K030719 is an FDA 510(k) premarket notification submitted by Oculus Optikgerate GmbH for the device "PENTACAM SCHEIMPFLUG CAMERA". The FDA issued a decision of Substantially Equivalent on September 16, 2003. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Oculus Optikgerate GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2003
- Date Received
- March 7, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Analysis, Anterior Segment
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type