510(k) K170071
- Device
- SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
- Applicant
- Sleep Group Solutions
- 510(k) number
- K170071
- Product code
- BXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-09
- Date received
- 2017-01-09
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rani Ben-David
- Address
- 2035 Harding St., Suite 200 Hollywood FL US 33020 33020
FDA Registration Numbers#
- 9710051
- 3011310592
- 3007075845
- 8040391
Source Documents#
Other 510(k) Records For Product Code BXQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221892 | VISIONAIR | Pacificmd Biotech, LLC | 2022-10-05 |
| K022311 | RHINOSTREAM RHINOMANOMETER MODULE | Rhino Metrics A/S | 2002-10-04 |
| K011329 | ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER | E. Benson Hood Lab, Inc. | 2002-07-26 |
| K000406 | RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE | Rhino Metrics A/S | 2000-04-17 |
| K972140 | A1 ACOUSTIC RHINOMETER | G.M. Instruments , Ltd. | 1998-09-30 |
| K921452 | ACOUSTIC RHINOMETER | Hood Laboratories | 1993-07-08 |
| K902120 | MERCURY RHINOMANOMETER | Life-Tech Intl., Inc. | 1990-08-06 |
| K896263 | RHINOMANOMETER | Jedmed Instrument Co. | 1990-04-16 |
| K853024 | RHINOTEST MP | Intertronic, Inc. | 1985-09-27 |
| K851143 | RHINOMANOMETERS NR3, NR4 | And/Or Corp. | 1985-05-23 |
| K844230 | RHINOMANOMETER A440 DIGITAL | Center Laboratories, Inc. | 1984-11-27 |
Legacy Summary#
summary
FDA Review#
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