ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
FDA 510(k) clearance K070739 · decided 2007-05-25
Clearance details
- K-number
- K070739
- Device name
- ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
- Applicant
- Renal Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-16
- Decision date
- 2007-05-25
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- FKT
- Device class
- 2
- Regulation number
- 876.5600
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Warrendale, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.