The following data is part of a premarket notification filed by Precise Optics with the FDA for Ps 3000 Digatal Photospot System.
| Device ID | K030061 |
| 510k Number | K030061 |
| Device Name: | PS 3000 DIGATAL PHOTOSPOT SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PRECISE OPTICS 1151 HOPE ST. Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen PRECISE OPTICS 1151 HOPE ST. Stamford, CT 06907 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-07 |
| Decision Date | 2003-04-07 |
| Summary: | summary |