DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
FDA 510(k) clearance K964922 · decided 1997-05-21
Clearance details
- K-number
- K964922
- Device name
- DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
- Decision
- Substantially Equivalent
- Date received
- 1996-12-09
- Decision date
- 1997-05-21
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.