Rhinoanemometer (measurement Of Nasal Decongestion)

Device Code: 41

Product Code(s): BXQ

Device Classification Information

Device Type ID41
Device NameRhinoanemometer (measurement Of Nasal Decongestion)
Regulation DescriptionRhinoanemometer.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number868.1800 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBXQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID41
DeviceRhinoanemometer (measurement Of Nasal Decongestion)
Product CodeBXQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRhinoanemometer.
CFR Regulation Number868.1800 [🔎]
Premarket Reviews
ManufacturerDecision
SLEEP GROUP SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 19:27:17

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