The following data is part of a premarket notification filed by Cgr Medical Corp. with the FDA for Stenoscop.
| Device ID | K843235 |
| 510k Number | K843235 |
| Device Name: | STENOSCOP |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
| Contact | Dennis E Upright |
| Correspondent | Dennis E 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 | 1984-08-16 |
| Decision Date | 1984-11-08 |