DIALYSIS MACHINE, CENTRY II
FDA 510(k) clearance K770857 · decided 1977-10-04
Clearance details
- K-number
- K770857
- Device name
- DIALYSIS MACHINE, CENTRY II
- Applicant
- Cobe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-09
- Decision date
- 1977-10-04
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- FJF
- 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 |
|---|---|---|
| MINNILERT AIR DETECTOR (K904992) | Minntech Corp. | 1991-02-05 |
| NICKLE-TITANIUM ORTHODONTIC WIRE (K891327) | American Orthodontics | 1989-05-10 |
| BLOOD LEVEL DETECTOR-MODEL 7601 (K781330) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-31 |
| DETECTOR, BUBBLE & FOAM (K780582) | Hospal Medical Corp. | 1978-06-22 |
Recalls involving this device
No recalls on record reference this clearance.