The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Modified Models 2000w And 2000w Option H Apnea Mon.
| Device ID | K905575 |
| 510k Number | K905575 |
| Device Name: | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON |
| Classification | Monitor, Breathing Frequency |
| Applicant | EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Gary Syring |
| Correspondent | Gary Syring 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 | 1990-12-12 |
| Decision Date | 1991-06-20 |