K170071 is an FDA 510(k) clearance for the SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer. This device is classified as a Rhinoanemometer (measurement Of Nasal Decongestion) (Class II - Special Controls, product code BXQ).
Submitted by Sleep Group Solutions (Hollywood, US). The FDA issued a Cleared decision on November 9, 2017, 304 days after receiving the submission on January 9, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1800.
| 510(k) Number | K170071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2017 |
| Decision Date | November 09, 2017 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BXQ — Rhinoanemometer (measurement Of Nasal Decongestion) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1800 |