The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Oxiflow Digital Recorder.
| Device ID | K953363 |
| 510k Number | K953363 |
| Device Name: | OXIFLOW DIGITAL RECORDER |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1996-02-06 |