The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelabs Pathfinder Sl Holter Analyzer.
| Device ID | K110001 |
| 510k Number | K110001 |
| Device Name: | SPACELABS PATHFINDER SL HOLTER ANALYZER |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke SPACELABS HEALTHCARE LTD. 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 | 2011-01-03 |
| Decision Date | 2011-06-14 |
| Summary: | summary |