Dialysis Machine, Centry II
FDA 510(k) K770857 · Cobe Laboratories, Inc.
510(k) numberK770857
Submission
- Device name
- Dialysis Machine, Centry II
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- May 9, 1977
- Decision date
- October 4, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJF – Detector, Air Bubble
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904992 | Minnilert Air DetectorFJF · Traditional | Minntech Corp. | 02/05/1991SE |
| K891327 | Nickle-Titanium Orthodontic WireFJF · Traditional | American Orthodontics | 05/10/1989SE |
| K781330 | Blood Level Detector-Model 7601FJF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/31/1978SE |
| K780582 | Detector, Bubble & FoamFJF · Traditional | Hospal Medical Corp. | 06/22/1978SE |
More from Hospal Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K900105 | Cobe Spectra Blood Component Separator TherapeuticLKN · Traditional | 03/22/1991SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
Questions and answers
When was Dialysis Machine, Centry II cleared by the FDA?
Dialysis Machine, Centry II (K770857) received a 510(k) decision of Substantially Equivalent on October 4, 1977, 148 days after the submission was received.
What is the product code of K770857?
The FDA product code is FJF – Detector, Air Bubble, a Class II (moderate risk) device regulated under 21 CFR 876.5820.