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510(k) Data Aggregation
K Number
K043614Device Name
VACULINK, MODEL VCL 3000
Manufacturer
MEDEVCO, INC.
Date Cleared
2005-04-14
(105 days)
Product Code
HDB
Regulation Number
884.4340Why did this record match?
Applicant Name (Manufacturer) :
MEDEVCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VacuLink is intended for obstetric use in the measurement and recording of data related to vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart.
Device Description
The VacuLink is a small, battery powered single-use vacuum measuring device. It is connected in parallel to the vacuum chamber of commercial handheld vacuum assisted delivery systems (i.e. Mityvac & Kiwi PalmPump). As a redundant gauge to the vacuum gauges on those devices, it electronically measures the vacuum applied to the fetal head during a vacuum assisted delivery. It connects to the vacuum port of the maternal/fetal monitor (i.e. HP, Corometrics and Spacelabs) via electrical cable. The vacuum value is numerically displayed in centimeters of mercury (cm Hg). The vacuum value is also recorded from the uterine activity channel of the maternal/fetal monitor and it is permanently stored in the hospital database. The information may also be displayed on a video monitor as well.
The VacuLink incorporates a light sequence of red, yellow, and green. When the VacuLink is first connected to the maternal/fetal monitor, all three lights will flash in sequence as a quick test of the internal components. At the successful completion of the test, the green LED illuminates until the VacuLink is disconnected from the maternal/fetal monitor. A flashing yellow LED illuminates when the battery voltage is low and the VacuLink should be replaced. If a VacuLink that has been used previously and is reconnected, the red LED illuminates indicating the VacuLink is no longer operational.
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