The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Sleep Test(tm).
| Device ID | K950273 |
| 510k Number | K950273 |
| Device Name: | SLEEP TEST(TM) |
| Classification | Ventilatory Effort Recorder |
| Applicant | CNS, INC. 1250 PARK RD. Chanhassen, MN 55317 |
| Contact | M.w. Andy Anderson |
| Correspondent | M.w. Andy Anderson CNS, INC. 1250 PARK RD. Chanhassen, MN 55317 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-23 |
| Decision Date | 1995-09-19 |