SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
FDA 510(k) clearance K060900 · decided 2006-06-23
Clearance details
- K-number
- K060900
- Device name
- SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
- Applicant
- Spacelabs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-03
- Decision date
- 2006-06-23
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- OLW
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Issaquah, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| SedLine Sedation Monitor (K260880) | Masimo Corporation | 2026-07-10 |
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| 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.