Tablo Hemodialysis System
FDA 510(k) clearance K200741 · decided 2020-03-31
Clearance details
- K-number
- K200741
- Device name
- Tablo Hemodialysis System
- Applicant
- Outset Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-23
- Decision date
- 2020-03-31
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.