FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
FDA 510(k) clearance K974584 · decided 1998-05-14
Clearance details
- K-number
- K974584
- Device name
- FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
- Applicant
- Fresenius USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-08
- Decision date
- 1998-05-14
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walnut Creek, 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.