The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Sleep I/t-5 And Sleep I/t-8.
| Device ID | K904432 |
| 510k Number | K904432 |
| Device Name: | SLEEP I/T-5 AND SLEEP I/T-8 |
| Classification | Monitor, Breathing Frequency |
| Applicant | CNS, INC. 1250 PARK RD. Chanhassen, MN 55317 |
| Contact | John Stolte |
| Correspondent | John Stolte CNS, INC. 1250 PARK RD. Chanhassen, MN 55317 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-28 |
| Decision Date | 1991-07-10 |