510(k) K022311

Device
RHINOSTREAM RHINOMANOMETER MODULE
Applicant
RHINOMETRICS A/S
510(k) number
K022311
Product code
BXQ  
Decision
Substantially Equivalent (SESE)
Decision date
2002-10-04
Date received
2002-07-17
Regulation
868.1800
Classification name
Rhinoanemometer (measurement Of Nasal Decongestion)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAN EGGAN
Address
9675 W. 95th St. Minneapolis MN US 55344 55344

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BXQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221892VISIONAIRPacificmd Biotech, LLC2022-10-05
K170071SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/PharyngometerSleep Group Solutions2017-11-09
K011329ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETERE. Benson Hood Lab, Inc.2002-07-26
K000406RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULERhino Metrics A/S2000-04-17
K972140A1 ACOUSTIC RHINOMETERG.M. Instruments , Ltd.1998-09-30
K921452ACOUSTIC RHINOMETERHood Laboratories1993-07-08
K902120MERCURY RHINOMANOMETERLife-Tech Intl., Inc.1990-08-06
K896263RHINOMANOMETERJedmed Instrument Co.1990-04-16
K853024RHINOTEST MPIntertronic, Inc.1985-09-27
K851143RHINOMANOMETERS NR3, NR4And/Or Corp.1985-05-23
K844230RHINOMANOMETER A440 DIGITALCenter Laboratories, Inc.1984-11-27

Legacy Summary#

summary

FDA Review#

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