The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Model 2000w Option H Configuration.
| Device ID | K871302 |
| 510k Number | K871302 |
| Device Name: | MODEL 2000W OPTION H CONFIGURATION |
| 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 | 1987-04-01 |
| Decision Date | 1987-04-20 |