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 |