The following data is part of a premarket notification filed by Lidco Ltd with the FDA for Lidcounity Monitor.
| Device ID | K152935 |
| 510k Number | K152935 |
| Device Name: | LiDCOunity Monitor |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | LIDCO LTD 16 ORSMAN ROAD London, GB N1 5qj |
| Contact | Eric Mills |
| Correspondent | Eric Mills LIDCO LTD 16 ORSMAN ROAD London, GB N1 5qj |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-05 |
| Decision Date | 2016-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060110523016 | K152935 | 000 |
| 05060110521852 | K152935 | 000 |
| 05060110521876 | K152935 | 000 |
| 05060110521883 | K152935 | 000 |
| 05060110521890 | K152935 | 000 |
| 05060110521937 | K152935 | 000 |
| 15060110521972 | K152935 | 000 |
| 05060110522002 | K152935 | 000 |
| 05060110522156 | K152935 | 000 |
| 15060110522429 | K152935 | 000 |
| 05060110522606 | K152935 | 000 |
| 05060110522781 | K152935 | 000 |
| 15060110522917 | K152935 | 000 |
| 05060110522941 | K152935 | 000 |
| 15060110520326 | K152935 | 000 |