The following data is part of a premarket notification filed by C.s.o. S.r.l. with the FDA for Cobra Fundus Camera.
| Device ID | K132987 |
| 510k Number | K132987 |
| Device Name: | COBRA FUNDUS CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | C.S.O. S.R.L. 110 EAST GRANADA BLVD, STE 209 Ormond Beach, FL 32716 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin C.S.O. S.R.L. 110 East Granada Blvd, Ste 209 Ormond Beach, FL 32716 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-24 |
| Decision Date | 2014-07-03 |
| Summary: | summary |