TABLO CARTRIDGE
FDA 510(k) clearance K140841 · decided 2014-09-11
Clearance details
- K-number
- K140841
- Device name
- TABLO CARTRIDGE
- Applicant
- Home Dialysis Plus
- Decision
- Substantially Equivalent
- Date received
- 2014-04-02
- Decision date
- 2014-09-11
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- FJK
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.