The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Eee.
| Device ID | K953540 |
| 510k Number | K953540 |
| Device Name: | EEE |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Chris Hadland |
| Correspondent | Chris Hadland EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-28 |
| Decision Date | 1995-08-25 |