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K Number
K000406

Validate with FDA (Live)

Device Name
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
Manufacturer
RHINOMETRICS A/S
Date Cleared
2000-04-17

(70 days)

Product Code
BXQ
Regulation Number
868.1800
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K092611
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.1800 Rhinoanemometer.

(a)
Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.(b)
Classification. Class II (performance standards).