VISIONAIR
FDA 510(k) clearance K221892 · decided 2022-10-05
Clearance details
- K-number
- K221892
- Device name
- VISIONAIR
- Applicant
- Pacificmd Biotech, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-06-29
- Decision date
- 2022-10-05
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- BXQ
- Device class
- 2
- Regulation number
- 868.1800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Henderson, NV, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer (K170071) | Sleep Group Solutions | 2017-11-09 |
| RHINOSTREAM RHINOMANOMETER MODULE (K022311) | Rhino Metrics A/S | 2002-10-04 |
| ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER (K011329) | E. Benson Hood Lab, Inc. | 2002-07-26 |
| RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE (K000406) | Rhino Metrics A/S | 2000-04-17 |
| A1 ACOUSTIC RHINOMETER (K972140) | G.M. Instruments , Ltd. | 1998-09-30 |
| ACOUSTIC RHINOMETER (K921452) | Hood Laboratories | 1993-07-08 |
| MERCURY RHINOMANOMETER (K902120) | Life-Tech Intl., Inc. | 1990-08-06 |
| RHINOMANOMETER (K896263) | Jedmed Instrument Co. | 1990-04-16 |
| RHINOTEST MP (K853024) | Intertronic, Inc. | 1985-09-27 |
| RHINOMANOMETERS NR3, NR4 (K851143) | And/Or Corp. | 1985-05-23 |
| RHINOMANOMETER A440 DIGITAL (K844230) | Center Laboratories, Inc. | 1984-11-27 |
Recalls involving this device
No recalls on record reference this clearance.