CHASE CARDIAC ANALYSIS SYSTEM— 510(k) K062031

Name: FDA 510(k) clearance K062031
Creator: U.S. Food and Drug Administration
Published: 2006-09-27

Substantially Equivalent

Chase Medical, LP

FDA 510(k) clearance K062031 for CHASE CARDIAC ANALYSIS SYSTEM, Substantially Equivalent on 2006-09-27. Applicant: Chase Medical, LP. Device class: 2.

Clearance details

Applicant: Chase Medical, LP
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2006-07-18
Decision date: 2006-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Chase Medical, LP

view all

K072473 — CHASE MR SYSTEM2007-12-10

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.