INOmax DSIR Plus
FDA 510(k) clearance K200389 · decided 2020-06-17
Clearance details
- K-number
- K200389
- Device name
- INOmax DSIR Plus
- Applicant
- Mallinckrodt Manufacturing, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-02-18
- Decision date
- 2020-06-17
- Days to decision
- 120 days
- Clearance type
- Special
- Product code
- MRN
- Device class
- 2
- Regulation number
- 868.5165
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.