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510(k) Data Aggregation
K Number
K120065Device Name
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
Manufacturer
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Date Cleared
2012-04-03
(85 days)
Product Code
JCX
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
PLAXTRON INDUSTRIAL (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection tubing that is connection val. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).
Device Description
Plaxtron Suction Unit, Model 88AA51/88AA61 series. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister.
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