The following data is part of a premarket notification filed by Astron Clinica Limited with the FDA for Siascope V.
| Device ID | K062736 |
| 510k Number | K062736 |
| Device Name: | SIASCOPE V |
| Classification | Light Based Imaging |
| Applicant | ASTRON CLINICA LIMITED 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith ASTRON CLINICA LIMITED 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Product Code | PSN |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2007-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628451918073 | K062736 | 000 |
| 00628451918004 | K062736 | 000 |