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510(k) Data Aggregation
K Number
K243138Device Name
Geon (S2) Nasal Aspirator
Manufacturer
Geon Corporation
Date Cleared
2025-02-04
(127 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Geon Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.
Device Description
Geon Nasal Aspirator, model S2, is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geon (S2) Nasal Aspirator is intended for over-the-counter (OTC) use at home environment. The main principle of operation is to utilize a pump to generate negative pressure in the suction system, which allows nasal secretions to flow into the device container.
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K Number
K220126Device Name
Geonic Nasal Aspirator, Geonic Nasal Cleaner
Manufacturer
Geon Corporation
Date Cleared
2023-02-02
(380 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Geon Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Geonic Nasal Aspirator (Model Name: AH2, S1) and Geonic Nasal Cleaner (Model Name: H2) are hand-held, noninvasive, electronic medical devices that pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geonic Nasal Cleaner (Model Name: H2) additionally provide positive pressure to moisturize the nasal cavities by using saline solution in the form of spray for adults and pediatrics (3 years old). The nasal aspirator and nasal cleaner are intended for over-the-counter (OTC) use at home environment.
Device Description
Not Found
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K Number
K100563Device Name
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
Manufacturer
GEON CORPORATION
Date Cleared
2010-06-02
(93 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
GEON CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an digital thermometers intended for the intermittent measurement of human body temperature either in oral, rectal and axillaries (underarm) , by consumers in the home for people of all ages.
Device Description
Geon Rapid Digital Thermometer, Model no.: MT-B117 ,MT-B127 ,MT-B130 ,MT-B132FA
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