Nautilus Smart ECMO Module
FDA 510(k) clearance K191935 · decided 2020-04-09
Clearance details
- K-number
- K191935
- Device name
- Nautilus Smart ECMO Module
- Applicant
- Mc3 Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2019-07-19
- Decision date
- 2020-04-09
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- BYS
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dexter, MI, US
- Third-party review
- No
- Expedited review
- No
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