The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Sensormedics 4000 Series Sleep System.
| Device ID | K915856 |
| 510k Number | K915856 |
| Device Name: | SENSORMEDICS 4000 SERIES SLEEP SYSTEM |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Raul L Kittinger |
| Correspondent | Raul L Kittinger SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-27 |
| Decision Date | 1992-10-26 |