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 |