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 |