510(k) K770857
- Device
- DIALYSIS MACHINE, CENTRY II
- Applicant
- Cobe Laboratories, Inc.
- 510(k) number
- K770857
- Product code
- FJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-10-04
- Date received
- 1977-05-09
- Regulation
- 876.5820
- Classification name
- Detector, Air Bubble
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FJF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904992 | MINNILERT AIR DETECTOR | Minntech Corp. | 1991-02-05 |
| K891327 | NICKLE-TITANIUM ORTHODONTIC WIRE | American Orthodontics | 1989-05-10 |
| K781330 | BLOOD LEVEL DETECTOR-MODEL 7601 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-31 |
| K780582 | DETECTOR, BUBBLE & FOAM | Hospal Medical Corp. | 1978-06-22 |