BXQ · Rhinoanemometer (Measurement Of Nasal Decongestion)
Anesthesiology · 21 CFR 868.1800 · Class 2
Overview
| Product Code | BXQ |
|---|---|
| Device Name | Rhinoanemometer (Measurement Of Nasal Decongestion) |
| Regulation | 21 CFR 868.1800 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221892 | VISIONAIR | Pacificmd Biotech, LLC | Oct 5, 2022 | SESE |
| K170071 | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer | Sleep Group Solutions | Nov 9, 2017 | SESE |
| K022311 | RHINOSTREAM RHINOMANOMETER MODULE | Rhino Metrics A/S | Oct 4, 2002 | SESE |
| K011329 | ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER | E. Benson Hood Lab, Inc. | Jul 26, 2002 | SESE |
| K000406 | RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE | Rhino Metrics A/S | Apr 17, 2000 | SESE |
| K972140 | A1 ACOUSTIC RHINOMETER | G.M. Instruments , Ltd. | Sep 30, 1998 | SESE |
| K921452 | ACOUSTIC RHINOMETER | Hood Laboratories | Jul 8, 1993 | SESE |
| K902120 | MERCURY RHINOMANOMETER | Life-Tech Intl., Inc. | Aug 6, 1990 | SESE |
| K896263 | RHINOMANOMETER | Jedmed Instrument Co. | Apr 16, 1990 | SESE |
| K853024 | RHINOTEST MP | Intertronic, Inc. | Sep 27, 1985 | SESE |
| K851143 | RHINOMANOMETERS NR3, NR4 | And/Or Corp. | May 23, 1985 | SESE |
| K844230 | RHINOMANOMETER A440 DIGITAL | Center Laboratories, Inc. | Nov 27, 1984 | SESE |
Top Applicants
- Rhino Metrics A/S — 2 clearances
- And/Or Corp. — 1 clearance
- Center Laboratories, Inc. — 1 clearance
- E. Benson Hood Lab, Inc. — 1 clearance
- G.M. Instruments , Ltd. — 1 clearance
