The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentec Model 2000w Apnea Monitor.
| Device ID | K844327 |
| 510k Number | K844327 |
| Device Name: | EDENTEC MODEL 2000W APNEA MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Edward Schuck |
| Correspondent | Edward Schuck EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-07 |
| Decision Date | 1985-07-15 |