Search Results
Found 1 results
510(k) Data Aggregation
K Number
K133870Device Name
FLUID LEVEL MONITOR
Manufacturer
Date Cleared
2014-04-24
(125 days)
Product Code
Regulation Number
880.2420Why did this record match?
Applicant Name (Manufacturer) :
COLEMAN LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid is low. The device provides both visual and audible alarms when preset condition is met.
The Fluid Level Monitor is intended for low-fluid-level alarm use in any healthcare setting where gravity flow infirsed. The use of the device improves efficiency within a busy medical setting by providing healthcare personnel of the low-fluid-level status.
LM771: 1-channel, DC battery power LM781: 1-channel, DC plug-in power LM785: 5-channel DC plug-in power
Device Description
Fluid Level Monitor is a passive sensing device that alarms when the infusion fluid level is low. Fluid Level Monitor provides both visual and audible alarms when preset condition is met. Fluid Level Monitor operates on DC power source.
Fluid Level Monitor includes both main control unit and external sensor. There are status LEDs on the main control unit to display run, alarm and battery-low status. There is a buzzer on the main control unit to provide audible alarm.
The external sensor is connected to the main control unit via shielded signal cable. The sensor can be clipped on the tubing to monitor fluid level.
Ask a Question
Ask a specific question about this device
Page 1 of 1