Gambro Bicarbonate Module, BCM-10
FDA 510(k) K810127 · Gambro, Inc.
510(k) numberK810127
Submission
- Device name
- Gambro Bicarbonate Module, BCM-10
- Applicant
- Gambro, Inc.
Mchenry, IL, US - Received
- January 19, 1981
- Decision date
- February 25, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKR – Subsystem, Proportioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K850435 | Sartorius Aquasart SM 40035 - Dialysate SysFKR · Traditional | Sartorius Filters, Inc. | 06/04/1985SE |
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| K810605 | Chematic Bicarbonate Dialysate SystemFKR · Traditional | Trimedyne, Inc. | 06/16/1981SE |
| K802465 | Bicarb-O-Mate Hemodialysis Sod. Bicarb.FKR · Traditional | Renal Systems, Inc. | 11/12/1980SE |
| K800772 | Mod. DM-357 Bicarbonate Retrofit KitFKR · Traditional | Extracorporeal Medical Specialities, Inc. | 05/14/1980SE |
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| K032431 | Prisma M60/M100 SetsKDI · Special | 09/15/2003SE |
| K896758 | Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional | 09/28/1990SE |
| K896757 | Gambro AK-10 Dialysis System for High FlowsFKP · Traditional | 08/30/1990SE |
| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | 07/27/1990SE |
| K900918 | Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional | 07/16/1990SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | 05/11/1989SE |
| K890112 | Engstrom Eliza + CO2 AnalyzerCCK · Traditional | 03/15/1989SE |
Questions and answers
When was Gambro Bicarbonate Module, BCM-10 cleared by the FDA?
Gambro Bicarbonate Module, BCM-10 (K810127) received a 510(k) decision of Substantially Equivalent on February 25, 1981, 37 days after the submission was received.
What is the product code of K810127?
The FDA product code is FKR – Subsystem, Proportioning, a Class II (moderate risk) device regulated under 21 CFR 876.5820.