Cobe RX Meter
FDA 510(k) K830629 · Cobe Laboratories, Inc.
510(k) numberK830629
Submission
- Device name
- Cobe RX Meter
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- March 1, 1983
- Decision date
- April 6, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLB – Meter, Conductivity, Induction, Remote Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FLB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100237 | Dialysate Meter, Model D-6FLB · Traditional | Myron L Company | 04/23/2010SE |
| K925210 | 90DX Multitest Meter, ModificationFLB · Traditional | Mesa Medical, Inc. | 01/25/1994SE |
| K882032 | Model 90DX Multitest MeterFLB · Traditional | Mesa Medical, Inc. | 08/11/1988SE |
| K821415 | Model 90 BCFLB · Traditional | Western Laboratories Corp. | 05/27/1982SE |
| K770263 | Dialysate Meter RS-2100A, Circuit ChangeFLB · Traditional | Renal Systems, Inc. | 02/18/1977SE |
More from Renal Systems, Inc.
| 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 Cobe RX Meter cleared by the FDA?
Cobe RX Meter (K830629) received a 510(k) decision of Substantially Equivalent on April 6, 1983, 36 days after the submission was received.
What is the product code of K830629?
The FDA product code is FLB – Meter, Conductivity, Induction, Remote Type, a Class II (moderate risk) device regulated under 21 CFR 876.5820.