The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Somno Star & Series Sleep System.
| Device ID | K012085 |
| 510k Number | K012085 |
| Device Name: | SOMNO STAR & SERIES SLEEP SYSTEM |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Linda Murdock |
| Correspondent | Linda Murdock SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-03 |
| Decision Date | 2001-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846446066050 | K012085 | 000 |
| 10190752173545 | K012085 | 000 |
| 10190752167629 | K012085 | 000 |
| 10190752161993 | K012085 | 000 |
| 10190752161122 | K012085 | 000 |