CARDTEL, MODEL NT-100— 510(k) K000609

Substantially Equivalent

Cardiac Telecommunications

FDA 510(k) clearance K000609 for CARDTEL, MODEL NT-100, Substantially Equivalent on 2000-05-23. Applicant: Cardiac Telecommunications.

Clearance details

Applicant: Cardiac Telecommunications
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2000-02-23
Decision date: 2000-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.