The following data is part of a premarket notification filed by Sis Ltd. Surgical Instrument Systems with the FDA for Cm 3910 Rotating Double Scheimpflug Camera.
| Device ID | K051940 |
| 510k Number | K051940 |
| Device Name: | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | SIS LTD. SURGICAL INSTRUMENT SYSTEMS 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SIS LTD. SURGICAL INSTRUMENT SYSTEMS 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167751235 | K051940 | 000 |