The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelabs Lifescreen Pro Analyzer.
| Device ID | K201921 |
| 510k Number | K201921 |
| Device Name: | Spacelabs Lifescreen PRO Analyzer |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Spacelabs Healthcare Ltd. Unit B, Foxholes Centre, John Tate Road Hertford, GB Sg13 7dt |
| Contact | Roger Moldon |
| Correspondent | Thomas Kroenke Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-10 |
| Decision Date | 2021-03-26 |