Gambro Engstrom Y Filter Pkg. Alone W/ Var.Models
FDA 510(k) K915154 · C.G.H. Medical, Inc.
510(k) numberK915154
Submission
- Device name
- Gambro Engstrom Y Filter Pkg. Alone W/ Var.Models
- Applicant
- C.G.H. Medical, Inc.
Lakewood, CO, US - Received
- November 14, 1991
- Decision date
- May 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAN – Regulator, Pressure, Gas Cylinder
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2700
- Specialty
- Anesthesiology
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| K950777 | Oxygen RegulatorCAN · Traditional | Mada Medical Products, Inc. | 04/14/1995SE |
| K942751 | Vanguard Series Gas RegulatorsCAN · Traditional | Buckman Co., Inc. | 02/09/1995SE |
| K936187 | Lspi Pressure RegulatorCAN · Traditional | Life Support Products, Inc. | 01/27/1994SE |
| K932006 | 1500 Series RegulatorCAN · Traditional | Precision Medical, Inc. | 10/25/1993SE |
| K921125 | Ambu Oxygen RegulatorCAN · Traditional | Amg, LLC | 09/17/1992SE |
| K915505 | Regulator FlowmeterCAN · Traditional | Lifeguard Medical Products, Inc. | 04/22/1992SE |
More from Lifeguard Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941708 | Cobe Centrysystem CS500 DialyzerFJI · Traditional | 05/12/1995SE |
| K933818 | Gambro Polyflux II Hemodialyzerialyzer HemodiafilterKDI · Traditional | 01/25/1995SE |
| K925522 | Centrysystem 3 with Charts/Bp OptionKOC · Traditional | 09/30/1994SE |
| K920757 | Filtral HemodialyzersKDI · Traditional | 08/05/1994SE |
| K931720 | Lundia Alpha 700 HemodialyzerKDI · Traditional | 07/07/1994SE |
| K924437 | Hemospal Kit B22 / Multiflow 60 KitKDI · Traditional | 06/27/1994SE |
| K940601 | Gambro Bicart 720GKPO · Traditional | 03/22/1994SE |
| K914271 | Gambro Engstrom Y-Filter with Edith Flex (1500F)CAN · Traditional | 04/13/1992SE |
| K915504 | Gambro Lundia Alpha HemodialyzersFJG · Traditional | 03/06/1992SE |
| K911603 | Hemospal Kit B22KDI · Traditional | 08/07/1991SE |
Questions and answers
When was Gambro Engstrom Y Filter Pkg. Alone W/ Var.Models cleared by the FDA?
Gambro Engstrom Y Filter Pkg. Alone W/ Var.Models (K915154) received a 510(k) decision of Substantially Equivalent on May 27, 1992, 195 days after the submission was received.
What is the product code of K915154?
The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.