BXQ · Class II · 21 CFR 868.1800

FDA Product Code BXQ: Rhinoanemometer (measurement Of Nasal Decongestion)

Leading manufacturers include Rhino Metrics A/S, Jedmed Instrument Co. and Life-Tech Intl., Inc..

12
Total
12
Cleared
197d
Avg days
1984
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Rhinoanemometer (measurement Of Nasal Decongestion) Devices (Product Code BXQ)

12 devices
1–12 of 12
Cleared Oct 05, 2022
VISIONAIR
K221892
Pacificmd Biotech, LLC
Ear, Nose, Throat · 98d
Cleared Nov 09, 2017
SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
K170071
Sleep Group Solutions
Anesthesiology · 304d
Cleared Oct 04, 2002
RHINOSTREAM RHINOMANOMETER MODULE
K022311
Rhino Metrics A/S
Anesthesiology · 79d
Cleared Jul 26, 2002
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
K011329
E. Benson Hood Lab, Inc.
Anesthesiology · 451d
Cleared Apr 17, 2000
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
K000406
Rhino Metrics A/S
Anesthesiology · 70d
Cleared Sep 30, 1998
A1 ACOUSTIC RHINOMETER
K972140
G.M. Instruments , Ltd.
Anesthesiology · 481d
Cleared Jul 08, 1993
ACOUSTIC RHINOMETER
K921452
Hood Laboratories
Anesthesiology · 469d
Cleared Aug 06, 1990
MERCURY RHINOMANOMETER
K902120
Life-Tech Intl., Inc.
Anesthesiology · 87d
Cleared Apr 16, 1990
RHINOMANOMETER
K896263
Jedmed Instrument Co.
Anesthesiology · 167d

About Product Code BXQ - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code BXQ since 1984, with 12 receiving FDA clearance (average review time: 197 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.