Quantum Pump Console— 510(k) K173834

Substantially Equivalent

Spectrum Medical , Ltd.

FDA 510(k) clearance K173834 for Quantum Pump Console, Substantially Equivalent on 2018-05-25. Applicant: Spectrum Medical , Ltd..

Clearance details

Applicant: Spectrum Medical , Ltd.
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2017-12-18
Decision date: 2018-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloucester, GB

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.