Model 460 Intermittent Medication Deliv
FDA 510(k) K823018 · Y
510(k) numberK823018
Submission
- Device name
- Model 460 Intermittent Medication Deliv
- Applicant
- Y
Mchenry, IL, US - Received
- October 13, 1982
- Decision date
- January 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLN – Monitor, Electric For Gravity Flow Infusion Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2420
- Specialty
- General Hospital
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|---|---|---|---|
| K172242 | DripAssist PlusFLN · Traditional | Shift Labs, Inc. | 05/25/2018SE |
| K150687 | DripAssistFLN · Traditional | Shift Labs | 10/13/2015SE |
| K133870 | Fluid Level MonitorFLN · Traditional | Coleman Laboratories | 04/24/2014SE |
| K080704 | Low Fluid AlarmFLN · Abbreviated | Em-Tec GmbH | 04/17/2008SE |
| K050783 | Issys Drug Flow MonitorFLN · Traditional | Integrated Sensing Systems, Inc. | 02/22/2006SE |
| K060123 | Levelert II Fluid Level SensorFLN · Special | Smith & Nephew, Inc. | 02/14/2006SE |
| K030136 | Drip AlertFLN · Traditional | Drip Alert, Inc. | 04/07/2003SE |
| K022248 | Stryker L3 HydrolertFLN · Traditional | Stryker Endoscopy | 08/06/2002SE |
| K013121 | MT Alert Infusion MonitorFLN · Traditional | Sierra Biosearch, Inc. | 10/15/2001SE |
| K973025 | Fluid Centurion (4-100-00)FLN · Traditional | Northgate Technologies, Inc. | 11/20/1997SE |
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| K960280 | Ivac Needle Free Valve Administration SetsFPA · Traditional | 04/04/1996SE |
| K953225 | Ivac Ball Valce Admin. SetsFPA · Traditional | 09/27/1995SE |
| K934095 | Ivac Vented Syringe Adapter Administration SetsFPA · Traditional | 08/10/1994SE |
| K940897 | Ivac Needleless Infection Valve Administration SetFPA · Traditional | 06/22/1994SE |
| K931550 | Ez Administration SetFPA · Traditional | 01/10/1994SE |
| K932544 | Ivac Space Saver Volumetric Pump, Model 599FRN · Traditional | 10/12/1993SE |
| K931549 | Model EZ-1 Sing CHAN/EZ-2 Dual Channel Infus PumpFRN · Traditional | 10/12/1993SE |
| K922115 | Ivac Needleless Injection ValveFPA · Traditional | 10/12/1993SE |
| K930781 | Infusion PumpFRN · Traditional | 08/19/1993SE |
Questions and answers
When was Model 460 Intermittent Medication Deliv cleared by the FDA?
Model 460 Intermittent Medication Deliv (K823018) received a 510(k) decision of Substantially Equivalent on January 26, 1983, 105 days after the submission was received.
What is the product code of K823018?
The FDA product code is FLN – Monitor, Electric For Gravity Flow Infusion Systems, a Class II (moderate risk) device regulated under 21 CFR 880.2420.