RS-7800 MINIPUMP
FDA 510(k) clearance K771705 · decided 1977-10-04
Clearance details
- K-number
- K771705
- Device name
- RS-7800 MINIPUMP
- Applicant
- Renal Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-09
- Decision date
- 1977-10-04
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- FIR
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ATI PLASMA PUMP (PP-04) (K961137) | Apheresis Technologies, Inc. | 1996-06-14 |
| INFUSION PUMP (K831953) | Cryosan, Inc. | 1983-07-19 |
| ASAHI BLOOD/PLASMA PUMP #ABP-01A & (K830818) | Parker Hannifin Corp. | 1983-04-12 |
| SPS-SINGLE PATIENT SYSTEM (K821139) | Extracorporeal Medical Specialities, Inc. | 1982-05-10 |
| BLOOD PUMP-MODE S10K (K780410) | 3M Health Care, Sarns | 1978-05-03 |
| HEPARIN PUMP (K761050) | Dws, Inc. | 1976-12-30 |
Recalls involving this device
No recalls on record reference this clearance.