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510(k) Data Aggregation
K Number
K142467Device Name
IntelAir Nasal Airway Support System
Manufacturer
Date Cleared
2014-11-24
(82 days)
Product Code
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
ABEON MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is indicated for use in patients requiring supplemental oxygenation, patients requiring capnographic monitoring, and patients requiring non-definitive airway support. To be used in one or any combination of the preceding circumstances.
Device Description
The subject device is a non-sterile, single-use airway support system that is intended to support airway patency, aid in supplemental oxygen delivery and assist in respiratory gas sample collection for capnogrpahy. The device consists of an airway tube, accessory tubes, and in some versions a magnetic securement system.
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K Number
K131506Device Name
AIRWAY SUPPORT SYSTEM / AIRPORT
Manufacturer
Date Cleared
2014-03-06
(286 days)
Product Code
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
ABEON MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AirPort is indicated for use in patients requiring supplemental oxygenation, patients requiring, and patients requiring non-definitive airway support. To be used in one or any combination of the preceding circumstances.
Device Description
Not Found
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