The following data is part of a premarket notification filed by Rhinometrics A/s with the FDA for Rhinoscan Model Sre2000/ Sre2100 With Acoustic Rhinometry Module.
| Device ID | K000406 |
| 510k Number | K000406 |
| Device Name: | RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE |
| Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
| Applicant | RHINOMETRICS A/S 555 13TH ST. N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein RHINOMETRICS A/S 555 13TH ST. N.W. Washington, DC 20004 -1109 |
| Product Code | BXQ |
| CFR Regulation Number | 868.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-04-17 |