Quantum Ventilation Module— 510(k) K202733

Substantially Equivalent

Spectrum Medical , Ltd.

FDA 510(k) clearance K202733 for Quantum Ventilation Module, Substantially Equivalent on 2020-10-16. Applicant: Spectrum Medical , Ltd..

Clearance details

Applicant: Spectrum Medical , Ltd.
Product code: Code DTX
Advisory panel: Cardiovascular
Date received: 2020-09-18
Decision date: 2020-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Gloucester, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTX

product code DTX

Death: 3
Malfunction: 497
Total: 500

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.