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510(k) Data Aggregation
K Number
K223258Device Name
TNI Clear-Guard 3 angled breathing filter (1545020)
Manufacturer
Intersurgical Ltd.
Date Cleared
2023-06-15
(237 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
Intersurgical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used only as part of the softFlow® 50 device to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. The filter should be positioned in a non-humidified gas flow.
Device Description
Clear-GuardTM 3 angled Breathing Filter, Model #1545020
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