Quantum Ventilation Module
FDA 510(k) clearance K181942 · decided 2018-10-18
Clearance details
- K-number
- K181942
- Device name
- Quantum Ventilation Module
- Applicant
- Spectrum Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-07-20
- Decision date
- 2018-10-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DTX
- Device class
- 2
- Regulation number
- 870.4300
- 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.