Quantum Workstation 12 Elite
FDA 510(k) clearance K202557 · decided 2020-10-02
Clearance details
- K-number
- K202557
- Device name
- Quantum Workstation 12 Elite
- Applicant
- Spectrum Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-03
- Decision date
- 2020-10-02
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DRY
- Device class
- 2
- Regulation number
- 870.4330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Gloucester, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.