Rhinoanemometer (Measurement Of Nasal Decongestion)
The Rhinoanemometer (Measurement of Nasal Decongestion) is a device used to measure nasal airflow resistance and assess the degree of nasal congestion or decongestion, aiding in the evaluation of nasal patency and response to treatment. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BXQ, regulated under 21 CFR 868.1800 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- BXQ
- Device Class
- FDA class 2
- Regulation Number
- 868.1800
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221892 | VISIONAIR | Oct 05, 2022 | Substantially Equivalent | Pacificmd Biotech, LLC |
| K170071 | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer | Nov 09, 2017 | Substantially Equivalent | Sleep Group Solutions |
| K022311 | RHINOSTREAM RHINOMANOMETER MODULE | Oct 04, 2002 | Substantially Equivalent | Rhino Metrics A/S |
| K011329 | ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER | Jul 26, 2002 | Substantially Equivalent | E. Benson Hood Lab, Inc. |
| K000406 | RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE | Apr 17, 2000 | Substantially Equivalent | Rhino Metrics A/S |
| K972140 | A1 ACOUSTIC RHINOMETER | Sep 30, 1998 | Substantially Equivalent | G.M. Instruments , Ltd. |
| K921452 | ACOUSTIC RHINOMETER | Jul 08, 1993 | Substantially Equivalent | Hood Laboratories |
| K902120 | MERCURY RHINOMANOMETER | Aug 06, 1990 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K896263 | RHINOMANOMETER | Apr 16, 1990 | Substantially Equivalent | Jedmed Instrument Co. |
| K853024 | RHINOTEST MP | Sep 27, 1985 | Substantially Equivalent | Intertronic, Inc. |
| K851143 | RHINOMANOMETERS NR3, NR4 | May 23, 1985 | Substantially Equivalent | And/Or Corp. |
| K844230 | RHINOMANOMETER A440 DIGITAL | Nov 27, 1984 | Substantially Equivalent | Center Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.