Sensormedics 4000 Series Sleep System
K915856 is the FDA 510(k) clearance record for SENSORMEDICS 4000 SERIES SLEEP SYSTEM, a class II device, cleared for Sensor Medics Corp. on under FDA product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph). FDA's definition for product code OLZ reads: "Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G...". FDA records list 26 510(k) clearances for Sensor Medics Corp., from to . As of , FDA records show no recalls naming K915856.
Clearance record
- Decision date
- Received
- (304 days to decision)
- Product code
- OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- Regulation
- 21 CFR 882.1400
- Device class
- Class II
- Review panel
- Neurology
- Applicant
- Sensor Medics Corp. 22705 Savi Ranch Pkwy., Yorba Linda CA
- 510(k) summary
- Summary
- Third party review
- No
Clearances, product code OLZ
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 1 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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