Quantum Workstation 12 Elite— 510(k) K202557
Substantially EquivalentSpectrum Medical , Ltd.
FDA 510(k) clearance K202557 for Quantum Workstation 12 Elite, Substantially Equivalent on 2020-10-02. Applicant: Spectrum Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Spectrum Medical , Ltd.
- Product code
- Code DRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gloucester, GB
Recent devices under product code DRY
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- K212657 — Quantum Heater-Cooler
- K210669 — Quantum Mini Ventilation Module
- K202733 — Quantum Ventilation Module
- K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.