The following data is part of a premarket notification filed by Lidco Ltd. with the FDA for Pulseco Hemodynamic Monitor Cm71.
| Device ID | K010049 |
| 510k Number | K010049 |
| Device Name: | PULSECO HEMODYNAMIC MONITOR CM71 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | LIDCO LTD. 16 ORSMAN RD. London, GB N15qj |
| Contact | Gregory Speller |
| Correspondent | Gregory Speller LIDCO LTD. 16 ORSMAN RD. London, GB N15qj |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-05 |
| Decision Date | 2001-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060110522774 | K010049 | 000 |
| 05060110520299 | K010049 | 000 |
| 05060110520305 | K010049 | 000 |
| 05060110520343 | K010049 | 000 |
| 05060110520534 | K010049 | 000 |
| 05060110520541 | K010049 | 000 |
| 05060110520558 | K010049 | 000 |
| 05060110520732 | K010049 | 000 |
| 05060110520756 | K010049 | 000 |
| 05060110520763 | K010049 | 000 |
| 15060110521019 | K010049 | 000 |
| 05060110521050 | K010049 | 000 |
| 05060110521470 | K010049 | 000 |
| 05060110521487 | K010049 | 000 |
| 05060110522118 | K010049 | 000 |
| 05060110522132 | K010049 | 000 |
| 05060110522569 | K010049 | 000 |
| 05060110520282 | K010049 | 000 |