The following data is part of a premarket notification filed by Sleep Group Solutions with the FDA for Sgs Eccovisiontm Pharyngometer, Sgs Eccovisiontm Rhinometer, Sgs Eccovisiontm Rhino/pharyngometer.
| Device ID | K170071 |
| 510k Number | K170071 |
| Device Name: | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer |
| Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
| Applicant | Sleep Group Solutions 2035 Harding Street, Suite 200 Hollywood, FL 33020 |
| Contact | Rani Ben-david |
| Correspondent | Stephen W Inglese Quality Solutions And Support, LLC PO BOX 8271 Holland, MI 49422 |
| Product Code | BXQ |
| CFR Regulation Number | 868.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860719000360 | K170071 | 000 |