The following data is part of a premarket notification filed by Lidco Ltd. with the FDA for Lidco System.
| Device ID | K962918 |
| 510k Number | K962918 |
| Device Name: | LIDCO SYSTEM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | LIDCO LTD. 16809 BRIARDALE RD. Rockville, MD 20850 |
| Contact | Tom Tsakeris |
| Correspondent | Tom Tsakeris LIDCO LTD. 16809 BRIARDALE RD. Rockville, MD 20850 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-27 |
| Decision Date | 1999-01-08 |
| Summary: | summary |