Quantum Workstation 12.1— 510(k) K181923

Substantially Equivalent

Spectrum Medical , Ltd.

FDA 510(k) clearance K181923 for Quantum Workstation 12.1, Substantially Equivalent on 2018-08-17. Applicant: Spectrum Medical , Ltd..

Clearance details

Applicant: Spectrum Medical , Ltd.
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 2018-07-18
Decision date: 2018-08-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Gloucester, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.