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 |