The following data is part of a premarket notification filed by Danam Electronics with the FDA for Danam Datacell-18.
| Device ID | K910283 |
| 510k Number | K910283 |
| Device Name: | DANAM DATACELL-18 |
| Classification | Counter, Differential Cell |
| Applicant | DANAM ELECTRONICS 4230 SHILLING WAY Dallas, TX 75237 |
| Contact | Jerry B West |
| Correspondent | Jerry B West DANAM ELECTRONICS 4230 SHILLING WAY Dallas, TX 75237 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-23 |
| Decision Date | 1991-04-12 |