Oxi-W System
FDA 510(k) clearance K200141 · decided 2020-04-27
Clearance details
- K-number
- K200141
- Device name
- Oxi-W System
- Applicant
- Ld Technology, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-01-21
- Decision date
- 2020-04-27
- Days to decision
- 97 days
- Clearance type
- Special
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.