Nobles-Lai Engineering Infusion Pump
FDA 510(k) K895688 · Nobles-Lai Engineering, Inc.
510(k) numberK895688
Submission
- Device name
- Nobles-Lai Engineering Infusion Pump
- Applicant
- Nobles-Lai Engineering, Inc.
Santa Ana, CA, US - Received
- September 22, 1989
- Decision date
- February 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQI – Withdrawal/Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1800
- Specialty
- Cardiovascular
Other 510(k)s with product code DQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960486 | Ksea Model 383320 20 AngiomatDQI · Traditional | Karl Storz Endoscopy | 10/25/1996SE |
| K935763 | SurgipumpDQI · Traditional | W.O.M. World of Medicine GmbH | 04/21/1994SE |
| K922541 | Usci Super 9 Ptca Guiding CatheterDQI · Traditional | C.R. Bard, Inc. | 12/08/1992SE |
| K924110 | Leocor Corflo Pump -- ModificationDQI · Traditional | Leocor, Inc. | 09/01/1992SE |
| K905189 | Baxter Angioscopy Pump Tubing Set (Model NL)DQI · Traditional | Baxter Healthcare Corp | 01/30/1991SE |
| K902444 | Clearview(Tm) Angioscopic Irrigation PumpDQI · Traditional | Intramed Laboratories, Inc. | 08/30/1990SE |
| K895074 | Angioscopy PumpDQI · Traditional | Baxter Healthcare Corp | 01/31/1990SE |
| K871422 | Olympus Angioscopy PumpDQI · Traditional | Olympus Corp. | 08/12/1987SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K953554 | Noblescope Neuroendoscope System & AccessoriesGWG · Traditional | 10/18/1995SE |
| K933345 | Nobles-Lai Endoscopic/LaparoscopicGCJ · Traditional | 02/22/1994SE |
| K920026 | Nobles-Lai Imaging SystemFET · Traditional | 07/28/1992SESK |
| K914457 | Disposable Optical ValvulotomeMGZ · Traditional | 02/05/1992SE |
Questions and answers
When was Nobles-Lai Engineering Infusion Pump cleared by the FDA?
Nobles-Lai Engineering Infusion Pump (K895688) received a 510(k) decision of Substantially Equivalent on February 26, 1990, 157 days after the submission was received.
What is the product code of K895688?
The FDA product code is DQI – Withdrawal/Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 870.1800.