FRESENIUS HEMODIALYSIS MACHINE A1008 BSM
FDA 510(k) clearance K855001 · decided 1986-01-21
Clearance details
- K-number
- K855001
- Device name
- FRESENIUS HEMODIALYSIS MACHINE A1008 BSM
- Applicant
- Seratronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-13
- Decision date
- 1986-01-21
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- FLC
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Concord, 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.
| Record | Firm | Date |
|---|---|---|
| WILSON-COOK DISPOSABLE BIOPSY FORCEPS (K910656) | Wilson-Cook Medical, Inc. | 1991-04-25 |
| NEGATOVE PRESSURE CONVERTOR (K791164) | Medicorp, Inc. | 1979-10-04 |
| COIL MACHINE ADAPTER (K760725) | Gambro, Inc. | 1976-10-27 |
Recalls involving this device
No recalls on record reference this clearance.