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510(k) Data Aggregation
K Number
K251133Device Name
AVEA disposable expiratory filter/water trap (11790)
Manufacturer
Telesair Inc.
Date Cleared
2025-05-08
(27 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Telesair Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator.
It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients.
It should be operated by properly trained clinical personnel, under the direction of a physician.
Device Description
The AVEA disposable expiratory filter/water trap is designed to be used exclusively with the AVEA Ventilator.
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