Tablo Console with Wireless Capability
FDA 510(k) clearance K150880 · decided 2015-05-01
Clearance details
- K-number
- K150880
- Device name
- Tablo Console with Wireless Capability
- Applicant
- Outset Medical
- Decision
- Substantially Equivalent
- Date received
- 2015-04-01
- Decision date
- 2015-05-01
- Days to decision
- 30 days
- Clearance type
- Special
- 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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Recalls involving this device
No recalls on record reference this clearance.