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510(k) Data Aggregation
K Number
K032322Device Name
CLEAR-THERM MICRO HME, MODEL 1441
Manufacturer
INTERSURGICAL, INC.
Date Cleared
2004-05-13
(290 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
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Matched: '868.5620'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intersurgical Clear-Therm Micro Filter is for use at the patient connection on the patient and equipment and is designed to reduce bacterial/viral contamination between patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the breathing circuit. Federal law restricts this device to sale by or on the order of a physician.
Device Description
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K Number
K033008Device Name
AIR SAFETY HEPA AND NON-HEPA FILTERS
Manufacturer
AIR SAFETY LTD
Date Cleared
2004-05-13
(230 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Search-Everything :
Matched: '868.5620'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Anesthesia / Respiratory Filters
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired.
Model – HEPA filter 3000/04 – Single patient use for exhalation limb of circuit on NPB 700 series ventilators
Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model – Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.
Device Description
The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate standard 15 / 22 mm connectors with or without a gas sampling luer port. Some models adapt to fit ventilator exhalation limb only. The depth (HEPA filtration) filter uses a pleated paper fiber for filtration. Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance. The "HEPA" performance was also tested in accordance to DOE-3025-99, DOE-3020-97 and ASTM D2986 - DOP. The electrostatic (non-HEPA filtration) filters are tested by Nelson Laboratories for BFE and VFE.
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