Fluid Level Monitor
FDA 510(k) K133870 · Coleman Laboratories
510(k) numberK133870
Submission
- Device name
- Fluid Level Monitor
- Applicant
- Coleman Laboratories
King Of Prussia, PA, US - Received
- December 20, 2013
- Decision date
- April 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
Other 510(k)s with product code FLN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172242 | DripAssist PlusFLN · Traditional | Shift Labs, Inc. | 05/25/2018SE |
| K150687 | DripAssistFLN · Traditional | Shift Labs | 10/13/2015SE |
| 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 |
| K972084 | Alexander Manufacturing Co. Rechargeable Battery Part Number M212FLN · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
More from Alexander Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K802256 | Triglycerides DeterminationCDT · Traditional | 10/23/1980SE |
Questions and answers
When was Fluid Level Monitor cleared by the FDA?
Fluid Level Monitor (K133870) received a 510(k) decision of Substantially Equivalent on April 24, 2014, 125 days after the submission was received.
What is the product code of K133870?
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.