A1 Acoustic Rhinometer

FDA 510(k) K972140 · G.M. Instruments , Ltd.

Substantially Equivalent

510(k) numberK972140

Submission

Device name
A1 Acoustic Rhinometer
Applicant
G.M. Instruments , Ltd.
Kilwinning, GB
Received
June 6, 1997
Decision date
September 30, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BXQ – Rhinoanemometer (Measurement Of Nasal Decongestion)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1800
Specialty
Anesthesiology

Other 510(k)s with product code BXQ

510(k)DeviceApplicantDecision
K221892VisionairBXQ · Traditional Pacificmd Biotech, LLC10/05/2022SE
K170071SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM…BXQ · Traditional Sleep Group Solutions11/09/2017SE
K022311Rhinostream Rhinomanometer ModuleBXQ · Traditional Rhino Metrics A/S10/04/2002SE
K011329Eccovision Acoustic Diagnostic Imaging Acoustic PharyngometerBXQ · Traditional E. Benson Hood Lab, Inc.07/26/2002SE
K000406Rhinoscan Model SRE2000/ SRE2100 with Acoustic Rhinometry ModuleBXQ · Traditional Rhino Metrics A/S04/17/2000SE
K921452Acoustic RhinometerBXQ · Traditional Hood Laboratories07/08/1993SE
K902120Mercury RhinomanometerBXQ · Traditional Life-Tech Intl., Inc.08/06/1990SE
K896263RhinomanometerBXQ · Traditional Jedmed Instrument Co.04/16/1990SE
K853024Rhinotest MPBXQ · Traditional Intertronic, Inc.09/27/1985SE
K851143Rhinomanometers NR3, NR4BXQ · Traditional And/Or Corp.05/23/1985SE

Questions and answers

When was A1 Acoustic Rhinometer cleared by the FDA?

A1 Acoustic Rhinometer (K972140) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 481 days after the submission was received.

What is the product code of K972140?

The FDA product code is BXQ – Rhinoanemometer (Measurement Of Nasal Decongestion), a Class II (moderate risk) device regulated under 21 CFR 868.1800.