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510(k) Data Aggregation
K Number
K251101Device Name
AIRO Suction Unit (AIRO-01)
Manufacturer
CRO, LLC
Date Cleared
2025-04-26
(15 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
CRO, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
Device Description
The AIRO Suction Unit, Model AIRO-01, is a compact, handheld, portable battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers such as emergency medical technicians, paramedics, and hospital personnel. The device is not intended for contact with patient tissue during procedures. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
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