SIII ALARM AMPLIFIER— 510(k) K011088

Substantially Equivalent

Stockert Instrumente GmbH

FDA 510(k) clearance K011088 for SIII ALARM AMPLIFIER, Substantially Equivalent on 2001-05-02. Applicant: Stockert Instrumente GmbH.

Clearance details

Applicant: Stockert Instrumente GmbH
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2001-04-10
Decision date: 2001-05-02
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.