The following data is part of a premarket notification filed by Hi-tech Medical Systems, Inc. with the FDA for Pc-display.
| Device ID | K862309 |
| 510k Number | K862309 |
| Device Name: | PC-DISPLAY |
| Classification | System, Image Processing, Radiological |
| Applicant | HI-TECH MEDICAL SYSTEMS, INC. 17155 NEWHOPE ST. SUITE G Fountain Vall, CA 92708 -4232 |
| Contact | Walter P Nachbaur |
| Correspondent | Walter P Nachbaur HI-TECH MEDICAL SYSTEMS, INC. 17155 NEWHOPE ST. SUITE G Fountain Vall, CA 92708 -4232 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-17 |
| Decision Date | 1986-11-12 |