FDA.reportPublic FDA data

510(k) K972140

Device
A1 ACOUSTIC RHINOMETER
Applicant
G.M. INSTRUMENTS LTD.
510(k) number
K972140
Product code
BXQ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-30
Date received
1997-06-06
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
E. W GREIG
Address
Unit 6, Ashgrove Ashgrove Rd. Kilwinning GB KA13 6PU KA13 6PU

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K022311RHINOSTREAM RHINOMANOMETER MODULERhino Metrics A/S2002-10-04
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
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases