BISX
FDA 510(k) clearance K040183 · decided 2004-02-25
Clearance details
- K-number
- K040183
- Device name
- BISX
- Applicant
- Aspect Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-27
- Decision date
- 2004-02-25
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- OLW
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Lafayette, CO, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Aspect Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SedLine Sedation Monitor (K260880) | Masimo Corporation | 2026-07-10 |
| BIS™ Advance Monitoring System (K230693) | Covidien, LLC | 2024-02-26 |
| Brain Anesthesia Response Monitor (Bar Monitor) (K213273) | Cortical Dynamics , Ltd. | 2023-09-01 |
| Masimo SedLine Sedation Monitor and Accessories (K203113) | Masimo Corporation | 2022-02-25 |
| NeuroSENSE Monitoring System, Model NS-901 (K202621) | Neurowave Systems, Inc. | 2021-08-05 |
| SedLine Sedation Monitor (K172890) | Masimo Corporation | 2018-01-26 |
| Entropy Module, E-ENTROPY-01 (K150298) | Ge Healthcare Filand OY | 2015-11-12 |
| BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (K083063) | Mennen Medical , Ltd. | 2008-12-16 |
| MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (K061907) | GE Healthcare | 2008-03-27 |
| BIS EEG VISTA MONITOR SYSTEM AND BISX (K072286) | Aspect Medical Systems, Inc. | 2007-11-20 |
| BIS MODULE FOR ENVOY PATIENT MONITOR (K071899) | Mennen Medical , Ltd. | 2007-10-22 |
| BIS EEG MONITOR VIEW (K062613) | Aspect Medical Systems, Inc. | 2007-06-18 |
Recalls involving this device
No recalls on record reference this clearance.