The following data is part of a premarket notification filed by Danam Electronics with the FDA for Datacell 18ms.
| Device ID | K945678 |
| 510k Number | K945678 |
| Device Name: | DATACELL 18MS |
| Classification | Counter, Differential Cell |
| Applicant | DANAM ELECTRONICS 4230 SHILLING WAY Dallas, TX 75237 |
| Contact | Jerry West |
| Correspondent | Jerry 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 | 1994-11-18 |
| Decision Date | 1995-09-12 |