The following data is part of a premarket notification filed by Minimally Invasive Devices Llc with the FDA for Clear-vu System, Models: Cvl-01-1000, Cvl-01-1030, Cvl-01-1045.
| Device ID | K080613 |
| 510k Number | K080613 |
| Device Name: | CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | MINIMALLY INVASIVE DEVICES LLC 1035 WALDO WAY Twinsburg, OH 44087 |
| Contact | Michael H Southworth |
| Correspondent | Michael H Southworth MINIMALLY INVASIVE DEVICES LLC 1035 WALDO WAY Twinsburg, OH 44087 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-04 |
| Decision Date | 2008-11-06 |
| Summary: | summary |