DIALOG DIALYSIS MACHINE
FDA 510(k) clearance K963440 · decided 1998-06-26
Clearance details
- K-number
- K963440
- Device name
- DIALOG DIALYSIS MACHINE
- Applicant
- B. Braun Medical AG
- Decision
- Substantially Equivalent
- Date received
- 1996-08-30
- Decision date
- 1998-06-26
- Days to decision
- 665 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and recall (Z-1531-2016) | B Braun Medical Inc | 2016-05-03 |
| Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # recall (Z-1532-2016) | B Braun Medical Inc | 2016-05-03 |
| Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Ser recall (Z-1533-2016) | B Braun Medical Inc | 2016-05-03 |
| Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U recall (Z-1534-2016) | B Braun Medical Inc | 2016-05-03 |
| Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can b recall (Z-1535-2016) | B Braun Medical Inc | 2016-05-03 |
| Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be recall (Z-1536-2016) | B Braun Medical Inc | 2016-05-03 |