The following data is part of a premarket notification filed by General Devices with the FDA for Dr-2c.
| Device ID | K844650 |
| 510k Number | K844650 |
| Device Name: | DR-2C |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | GENERAL DEVICES 86 HARRIET AVE. Bergenfield, NJ 07621 |
| Contact | Michael Smith |
| Correspondent | Michael Smith GENERAL DEVICES 86 HARRIET AVE. Bergenfield, NJ 07621 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-29 |
| Decision Date | 1985-01-22 |