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510(k) Data Aggregation
K Number
K160950Device Name
MINISCAV
Manufacturer
Sedation Systems LLC
Date Cleared
2017-05-05
(395 days)
Product Code
CBN, BTA
Regulation Number
868.5430Why did this record match?
Applicant Name (Manufacturer) :
Sedation Systems LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.
This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
Device Description
The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.
The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.
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