The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Sentinel Cardiology Information Management System.
| Device ID | K152881 |
| 510k Number | K152881 |
| Device Name: | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | SPACELABS HEALTHCARE LTD. 1 HARFORDE COURT JOHN TATE ROAD Hertford, GB Sg13 7nw |
| Contact | Al Van Houdt |
| 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 | 2015-09-30 |
| Decision Date | 2016-04-01 |
| Summary: | summary |