The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelabs Healthcare Cardioexpress.
| Device ID | K130207 |
| 510k Number | K130207 |
| Device Name: | SPACELABS HEALTHCARE CARDIOEXPRESS |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-28 |
| Decision Date | 2013-07-23 |
| Summary: | summary |