STOCKERT COMPACT SYSTEM VERSION 2.0— 510(k) K002118

Substantially Equivalent

Stoeckert Instrumente

FDA 510(k) clearance K002118 for STOCKERT COMPACT SYSTEM VERSION 2.0, Substantially Equivalent on 2000-08-09. Applicant: Stoeckert Instrumente.

Clearance details

Applicant: Stoeckert Instrumente
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2000-07-13
Decision date: 2000-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.