510(k) K051940
K051940 is an FDA 510(k) premarket notification submitted by Sis Ltd., Surgical Instrument Systems for the device "CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA". The FDA issued a decision of Substantially Equivalent on September 28, 2005. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Sis Ltd., Surgical Instrument Systems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2005
- Date Received
- July 18, 2005
- 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