The following data is part of a premarket notification filed by Rhinometrics A/s with the FDA for Rhinostream Rhinomanometer Module.
| Device ID | K022311 |
| 510k Number | K022311 |
| Device Name: | RHINOSTREAM RHINOMANOMETER MODULE |
| Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
| Applicant | RHINOMETRICS A/S 9675 WEST 95TH ST. Minneapolis, MN 55344 |
| Contact | Dan Eggan |
| Correspondent | Dan Eggan RHINOMETRICS A/S 9675 WEST 95TH ST. Minneapolis, MN 55344 |
| Product Code | BXQ |
| CFR Regulation Number | 868.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-17 |
| Decision Date | 2002-10-04 |
| Summary: | summary |