The following data is part of a premarket notification filed by Precise Optics with the FDA for P2020-8-0 Beam-limiting Device.
| Device ID | K914184 |
| 510k Number | K914184 |
| Device Name: | P2020-8-0 BEAM-LIMITING DEVICE |
| Classification | Device, Beam Limiting, X-ray, Diagnostic |
| Applicant | PRECISE OPTICS 239 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Contact | John D Marco |
| Correspondent | John D Marco PRECISE OPTICS 239 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Product Code | KPW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-18 |
| Decision Date | 1991-11-27 |