The following data is part of a premarket notification filed by Michelson Diagnostics Ltd. with the FDA for Vivosight Topical Oct System.
| Device ID | K093520 |
| 510k Number | K093520 |
| Device Name: | VIVOSIGHT TOPICAL OCT SYSTEM |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | MICHELSON DIAGNOSTICS LTD. 11A GRAYS FARM PRODUCTION VILL GRAYS FARM ROAD Orpington, Kent, GB Br5 3bd |
| Contact | Martin Johns |
| Correspondent | Martin Johns MICHELSON DIAGNOSTICS LTD. 11A GRAYS FARM PRODUCTION VILL GRAYS FARM ROAD Orpington, Kent, GB Br5 3bd |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-13 |
| Decision Date | 2010-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060507260005 | K093520 | 000 |