The following data is part of a premarket notification filed by Cgr Medical Corp. with the FDA for Hyperlux 30 Image System.
| Device ID | K827489 |
| 510k Number | K827489 |
| Device Name: | HYPERLUX 30 IMAGE SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
| Contact | Dennis Upright |
| Correspondent | Dennis Upright CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-04 |
| Decision Date | 1982-11-04 |