The following data is part of a premarket notification filed by Astron Clinica Limited with the FDA for Siascope Ii.
| Device ID | K023729 |
| 510k Number | K023729 |
| Device Name: | SIASCOPE II |
| Classification | Light Based Imaging |
| Applicant | ASTRON CLINICA LIMITED PO BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith ASTRON CLINICA LIMITED PO BOX 4341 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 | 2002-11-06 |
| Decision Date | 2003-02-03 |