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510(k) Data Aggregation
K Number
K063526Device Name
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
Manufacturer
A-M SYSTEMS, INC.
Date Cleared
2007-06-29
(219 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
A-M SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is indicated for use on all patient populations, in conjunction with other respirations devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
Device Description
The A-M SYSTEMS VIROMAX Viral and Bacterial Filter is a non-sterile, single patient use breathing filter consisting of a gas permeable filter membrane enclosed in a transparent plastic housing. When the A-M SYSTEMS Viral and Bacterial Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter membrane, thus trapping bacteria and viruses.
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K Number
K000654Device Name
VBMAX
Manufacturer
A-M SYSTEMS, INC.
Date Cleared
2000-11-14
(260 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
A-M SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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